text:
Senior Luckenbach's stressful second semester
Luckenbach as Muzzy van Hossmere in "Thoroughly Modern Millie"
Claire Porter, Staff Writer
While many seniors are enjoying this application-free semester, senior Catherine Luckenbach, majoring in Musical Theater, has her most vital part of her application to stress about.
"Most seniors absolutely love knowing that they are a second semester senior because all of their college application processes are over. However, the most important part of my college acceptances are in my second semester," said Luckenbach.
Luckenbach has been an aspiring actor from a young age. Since third grade, she has been in about 14 shows. And to her, musical theater was never something she had to think about– she knew this would always be her passion.
Her college applications don't just consist of the standard online application, but she must also send in prescreen videos to schools. Luckenbach fortunately got past all her prescreens, and now has 13 in-person auditions to complete.
"Catherine had to throw out a much wider net in order to increase her chances of being admitted to other schools. She had way more applications to do than most students," said senior Kalila Kirk. "I really admire her for persevering through this extra difficult process."
Musical theatre is a very competitive field. Schools only take about 10 to 13 female applicants, and even more selective schools take no more than six. At auditions, Luckenbach is competing against thousands of other young women for a very small amount of spots based on short, 10 minute auditions.
The auditions are intense. Many have nerve-wracking procedures, such as rescinding an audition if a song is more than 16 bars, a practice which University of Michigan is known for doing.
"Penn State 'taps you out' of the dance audition if you aren't up to their standards, and if you are 'tapped out,' you are unable to sing or act for the school," said Luckenbach.
Within the next few months, she must travel to Chicago, twice to Los Angeles, New York, and North Carolina to complete these auditions. In preparation, Luckenbach has rehearsed numerous songs, monologues, and dances with both her college audition coach and voice instructor.
Luckebach also stated, "Of course I wish I could have a 'normal' second semester because I would have a significantly less amount of stress, but having my auditions second semester has allowed me to thoroughly prepare for my auditions."
In the end, Luckenbach remains positive about her stressful second semester endeavour. "I'm attempting to look at the audition process as an opportunity to do what I love most, rather than a challenge in which I must prove myself."
luckenbach's
ASB member for four years
Student Trustee to the SUHSD for the 2013-2014 school year
USC Trojan Class of 2018
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redpajama_set_name: RedPajamaCommonCrawl


Watch the American metal band have the time of their life.
CORRECTION: An earlier version of this story said that James Hetfield was the guitarist. Kirk Hammett was on guitar. We've updated this article accordingly.
Currently on the European leg of their globe-spanning Worldwired tour, James Hetfield and Co. have fallen into a little tradition of sprinkling into their set a cover of a song that honours a musical artist from the city they're playing in; highlights from these tributes include Falco's europop forever-jam "Rock Me Amadeus" in Vienna and A-ha's earworm 'Take On Me' in during their Norway stop.
Although it wasn't a Friday night, the lights were low when the group took the stage in Stockholm, Sweden and offered their own take on the classic song by the newly-resurrected, soon-to-be-hologrammified ABBA .
The cover—performed by Kirk Hammet on guitar and bassist Rob Trujillo, who also took over vocal duties from the 'Het—comes out sounding kind of like if "Dancing Queen" existed in an alternate timeline as a half-baked 90's Red Hot Chili Peppers B-side, and whether or not that sounds like your cup of tea, it still got the crowd chanting along.


text:
Whiskey Business – Econlib
By Meg Perkins Last updated Dec 26, 2022
What prompts a young scholar to leave the academy…and open a distillery? If you're Sonata Birlinger-Hart and her husband, it seemed clear. Thus, Koval was born. In this episode, EconTalk host Russ Roberts welcomes Hart to talk about her journey. And yes, he brings out the economics in the story, too!
The couple learned a lot about making whiskey- and perhaps more about business and politics. Just to get started, for example, they had to get laws changed so they could operate a bar in their space. It's fair to say the duo changed the nature of all distilling in Illinois.
They also found advantages to being a small producer. There were less than 50 distilleries in all of America when they started Koval. Today, there are more than 2,000. Hart hoped they could make something better, both in a traditional whiskey and in whiskeys made from new grains, such as millet.
I learned a lot about this business- the good, the bad, and the ugly- from this episode. And now I wonder what you took away from the conversation. I hope you'll help us continue it. Cheers!
1- How does Hart describe the initial division of labor at Koval? How did they "play futures with their growth" and begin replicating vertical business models around the world? What did you find most unique about this start-up story?
2-Hart and Roberts spend a good bit of time discussing quality control. How can you make the same whiskey (or sourdough bread) every time? How has Koval managed to leverage technology in their production process, yet still maintain the advantages of small-scale craft distilling?
3- Among the many things I learned from this conversation was that the center of US distilling in the early 1900s was in Peoria, Illinois! How did the "Chicago barley mafia" alter the industry after the discovery of using enzymes, rather than malting, to distill? Roberts starts to dub this a Bootleggers and Baptists story, but changes his mind. Why isn't it a Bootleggers and Baptists story?
4- Roberts asks Hart how they know how long to distill, "because there's a trade-off–classic economics–that your money is sitting in the barrel." What does this trade-off entail, and how do they manage this at Koval?
5- The episode closes with discussion about the challenges Hart initially faced with distribution. What were these challenges, and why don't these challenges create an opportunity for a newcomer to create a different model, as Roberts suggests? What are the barriers to entry, and what would you recommend be done to mitigate them?
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text:
Title 21 Part 892
Title 21 → Chapter I → Subchapter H → Part 892
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart A—General Provisions
§892.1 Scope.
§892.3 Effective dates of requirement for premarket approval.
§892.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Subpart B—Diagnostic Devices
§892.1000 Magnetic resonance diagnostic device.
§892.1100 Scintillation (gamma) camera.
§892.1110 Positron camera.
§892.1130 Nuclear whole body counter.
§892.1170 Bone densitometer.
§892.1180 Bone sonometer.
§892.1200 Emission computed tomography system.
§892.1220 Fluorescent scanner.
§892.1300 Nuclear rectilinear scanner.
§892.1310 Nuclear tomography system.
§892.1320 Nuclear uptake probe.
§892.1330 Nuclear whole body scanner.
§892.1350 Nuclear scanning bed.
§892.1360 Radionuclide dose calibrator.
§892.1370 Nuclear anthropomorphic phantom.
§892.1380 Nuclear flood source phantom.
§892.1390 Radionuclide rebreathing system.
§892.1400 Nuclear sealed calibration source.
§892.1410 Nuclear electrocardiograph synchronizer.
§892.1420 Radionuclide test pattern phantom.
§892.1540 Nonfetal ultrasonic monitor.
§892.1550 Ultrasonic pulsed doppler imaging system.
§892.1560 Ultrasonic pulsed echo imaging system.
§892.1570 Diagnostic ultrasonic transducer.
§892.1600 Angiographic x-ray system.
§892.1610 Diagnostic x-ray beam-limiting device.
§892.1620 Cine or spot fluorographic x-ray camera.
§892.1630 Electrostatic x-ray imaging system.
§892.1640 Radiographic film marking system.
§892.1650 Image-intensified fluoroscopic x-ray system.
§892.1660 Non-image-intensified fluoroscopic x-ray system.
§892.1670 Spot-film device.
§892.1680 Stationary x-ray system.
§892.1700 Diagnostic x-ray high voltage generator.
§892.1710 Mammographic x-ray system.
§892.1715 Full-field digital mammography system.
§892.1720 Mobile x-ray system.
§892.1730 Photofluorographic x-ray system.
§892.1740 Tomographic x-ray system.
§892.1750 Computed tomography x-ray system.
§892.1760 Diagnostic x-ray tube housing assembly.
§892.1770 Diagnostic x-ray tube mount.
§892.1820 Pneumoencephalographic chair.
§892.1830 Radiologic patient cradle.
§892.1840 Radiographic film.
§892.1850 Radiographic film cassette.
§892.1860 Radiographic film/cassette changer.
§892.1870 Radiographic film/cassette changer programmer.
§892.1880 Wall-mounted radiographic cassette holder.
§892.1890 Radiographic film illuminator.
§892.1900 Automatic radiographic film processor.
§892.1910 Radiographic grid.
§892.1920 Radiographic head holder.
§892.1940 Radiologic quality assurance instrument.
§892.1950 Radiographic anthropomorphic phantom.
§892.1960 Radiographic intensifying screen.
§892.1970 Radiographic ECG/respirator synchronizer.
§892.1980 Radiologic table.
§892.1990 Transilluminator for breast evaluation.
§892.2010 Medical image storage device.
§892.2020 Medical image communications device.
§892.2030 Medical image digitizer.
§892.2040 Medical image hardcopy device.
§892.2050 Picture archiving and communications system.
Subparts C-E [Reserved]
Subpart F—Therapeutic Devices
§892.5050 Medical charged-particle radiation therapy system.
§892.5300 Medical neutron radiation therapy system.
§892.5650 Manual radionuclide applicator system.
§892.5700 Remote controlled radionuclide applicator system.
§892.5710 Radiation therapy beam-shaping block.
§892.5720 Rectal balloon for prostate immobilization.
§892.5725 Absorbable perirectal spacer.
§892.5730 Radionuclide brachytherapy source.
§892.5740 Radionuclide teletherapy source.
§892.5750 Radionuclide radiation therapy system.
§892.5770 Powered radiation therapy patient support assembly.
§892.5780 Light beam patient position indicator.
§892.5840 Radiation therapy simulation system.
§892.5900 X-ray radiation therapy system.
§892.5930 Therapeutic x-ray tube housing assembly.
Subpart G—Miscellaneous Devices
§892.6500 Personnel protective shield.
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Editorial Note: Nomenclature changes to part 892 appear at 73 FR 35341, June 23, 2008.
(a) This part sets forth the classification of radiology devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by §807.87.
(c) To avoid duplicative listings, a radiology device that has two or more types of uses (e.g., use both as a diagnostic device and a therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of this title 21, unless otherwise noted.
(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm..
[53 FR 1567, Jan. 20, 1988, as amended at 73 FR 40969, July 17, 2008; 78 FR 18233, Mar. 26, 2013]
A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.
(a) Before FDA requires that a device commercially distributed before the enactment date of the amendments, or a device that has been found substantially equivalent to such a device, has an approval under section 515 of the act, FDA must promulgate a regulation under section 515(b) of the act requiring such approval, except as provided in paragraph (b) of this section. Such a regulation under section 515(b) of the act shall not be effective during the grace period ending on the 90th day after its promulgation or on the last day of the 30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:
(a) The device is intended for a use different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;
(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for screening, diagnosis, or monitoring life-threatening diseases such as acquired immune deficiency syndrome (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or to monitor therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism directly from clinical material;
(7) For detection of antibodies to microorganisms other than immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or are used to determine immunity, or the assay is intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in §812.3(k) of this chapter; and
(9) For near patient testing (point of care).
[65 FR 2322, Jan. 14, 2000]
(a) Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
(b) Classification. Class II.
[53 FR 5078, Feb. 1, 1989]
(a) Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(b) Classification. Class I (general controls).
[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001]
(a) Identification. A positron camera is a device intended to image the distribution of positron-emitting radionuclides in the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(a) Identification. A nuclear whole body counter is a device intended to measure the amount of radionuclides in the entire body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, 2001]
[55 FR 48444, Nov. 20, 1990]
(a) Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A bone sonometer is a device that transmits ultrasound energy into the human body to measure acoustic properties of bone that indicate overall bone health and fracture risk. The primary components of the device are a voltage generator, a transmitting transducer, a receiving transducer, and hardware and software for reception and processing of the received ultrasonic signal.
(b) Classification. Class II (special controls). The special control for this device is FDA's "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Bone Sonometers." See §892.1(e) for the availability of this guidance document.
[73 FR 40969, July 17, 2008]
(a) Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(a) Identification. A fluorescent scanner is a device intended to measure the induced fluorescent radiation in the body by exposing the body to certain x-rays or low-energy gamma rays. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories.
(a) Identification. A nuclear rectilinear scanner is a device intended to image the distribution of radionuclides in the body by means of a detector (or detectors) whose position moves in two directions with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 FR 38818, July 25, 2001]
(a) Identification. A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(a) Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.
[55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000]
(a) Identification. A nuclear whole body scanner is a device intended to measure and image the distribution of radionuclides in the body by means of a wide-aperture detector whose position moves in one direction with respect to the patient. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.
(a) Identification. A nuclear scanning bed is an adjustable bed intended to support a patient during a nuclear medicine procedure.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 65 FR 2322, Jan. 14, 2000]
(a) Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
(a) Identification. A nuclear anthropomorphic phantom is a human tissue facsimile that contains a radioactive source or a cavity in which a radioactive sample can be inserted. It is intended to calibrate nuclear uptake probes or other medical instruments.
[53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38818, July 25, 2001]
(a) Identification. A nuclear flood source phantom is a device that consists of a radiolucent container filled with a uniformly distributed solution of a desired radionuclide. It is intended to calibrate a medical gamma camera-collimator system for uniformity of response.
(a) Identification. A radionuclide rebreathing system is a device intended to be used to contain a gaseous or volatile radionuclide or a radionuclide-labeled aerosol and permit it to be respired by the patient during nuclear medicine ventilatory tests (testing process of exchange between the lungs and the atmosphere). This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A nuclear sealed calibration source is a device that consists of an encapsulated reference radionuclide intended for calibration of medical nuclear radiation detectors.
(a) Identification. A nuclear electrocardiograph synchronizer is a device intended for use in nuclear radiology to relate the time of image formation to the cardiac cycle during the production of dynamic cardiac images.
(a) Identification. A radionuclide test pattern phantom is a device that consists of an arrangement of radiopaque or radioactive material sealed in a solid pattern intended to serve as a test for a performance characteristic of a nuclear medicine imaging device.
(a) Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
(a) Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
(a) Identification. A cine or spot fluorographic x-ray camera is a device intended to photograph diagnostic images produced by x-rays with an image intensifier.
(a) Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A radiographic film marking system is a device intended for medical purposes to add identification and other information onto radiographic film by means of exposure to visible light.
[55 FR 48444, Nov. 20, 1990, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]
(a) Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) Classification. Class II. When intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 57369, Nov. 15, 2001]
(a) Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A spot-film device is an electromechanical component of a fluoroscopic x-ray system that is intended to be used for medical purposes to position a radiographic film cassette to obtain radiographs during fluoroscopy.
(a) Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]
(a) Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.
(b) Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Full-Field Digital Mammography System." See §892.1(e) for the availability of this guidance document.
[75 FR 68203, Nov. 5, 2010]
(a) Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(a) Identification. A diagnostic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.
(a) Identification. A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.
(a) Identification. A pneumoencephalographic chair is a chair intended to support and position a patient during pneumoencephalography (x-ray imaging of the brain).
(a) Identification. A radiologic patient cradle is a support device intended to be used for rotational positioning about the longitudinal axis of a patient during radiologic procedures.
(a) Identification. Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]
(a) Identification. A radiographic film cassette is a device intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and to provide a light-proof enclosure for direct exposure of radiographic film.
(a) Identification. A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
(a) Identification. A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.
(a) Identification. A wall-mounted radiographic cassette holder is a device that is a support intended to hold and position radiographic cassettes for a radiographic exposure for medical use.
(a) Identification. A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.
(a) Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.
(a) Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.
[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]
(a) Identification. A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.
(a) Identification. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
(a) Identification. A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.
(a) Identification. A radiographic intensifying screen is a device that is a thin radiolucent sheet coated with a luminescent material that transforms incident x-ray photons into visible light and intended for medical purposes to expose radiographic film.
(a) Identification. A radiographic ECG/respirator synchronizer is a device intended to be used to coordinate an x-ray film exposure with the signal from an electrocardiograph (ECG) or respirator at a predetermined phase of the cardiac or respiratory cycle.
(a) Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 63 FR 59231, Nov. 3, 1998]
(a) Identification. A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.
(b) Classification. Class III (premarket approval).
(c) Date premarket approval (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976. Any other transilluminator for breast evaluation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
[60 FR 36639, July 18, 1995, as amended at 79 FR 3094, Jan. 17, 2014]
(a) Identification. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.
[63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. 24, 1998, as amended at 65 FR 2323, Jan. 14, 2000]
(a) Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol.
(a) Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.
(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.).
[63 FR 23387, Apr. 29, 1998]
(a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.
(b) Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
(a) Identification. A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.
(a) Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(b) Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §892.9.
[53 FR 1567, Jan. 20, 1988, as amended at 64 FR 1125, Jan. 8, 1999]
(a) Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.
(a) Identification. A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
(a) Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.
(a) Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.
(a) Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:
(i) Biocompatibility testing of the final finished device;
(ii) If provided sterile, sterilization validation;
(iii) If not provided sterile, bioburden testing of the final finished device;
(iv) Shelf life and expiration date validation; and
(v) Performance testing including but not limited to:
(A) Venting mechanism (if device has a vent mechanism);
(B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and
(C) Structural integrity testing (e.g., tensile strength, balloon leakage and burst strength).
(2) Labeling that includes:
(i) Appropriate warnings and contraindications, including, but not limited to the following statements:
(A) "Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.";
(B) "Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.";
(C) "Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation."; and
(D) "Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon."
(ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;
(iii) Whether the device is sterile or non-sterile; and
(iv) An expiration date.
(a) Identification. An absorbable perirectal spacer is composed of biodegradable material that temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer with the intent to reduce the radiation dose delivered to the anterior rectum. The absorbable spacer maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.
(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing. For all clinical investigations used to support premarket notification submissions for this type of device, line listings of the study data must be provided.
(i) Performance bench testing must demonstrate appropriate perirectal space creation and maintenance for the duration of prostate radiotherapy.
(ii) Performance bench testing must demonstrate that therapeutic radiation levels do not alter the performance of the device.
(iii) Performance in vivo testing must demonstrate appropriate deployment of spacer as indicated in the accompanying labeling, and demonstrate appropriate expansion and absorption characteristics in a clinically relevant environment.
(iv) Clinical study must demonstrate appropriate spacer stability and lack of migration for the entire course of radiotherapy, complete absorption, and lack of long term toxicity.
(v) Sterility testing must demonstrate the sterility of the device and the effects of the sterilization process on the physical characteristics of the spacer.
(vi) Shelf-life testing must demonstrate the stability of the physical characteristics of the spacer throughout the shelf-life as indicated in the accompanying labeling.
(vii) The device must be demonstrated to be biocompatible.
(2) The risk management activities performed as part of the manufacturer's §820.30 design controls must document an appropriate end user initial training program which will be offered as part of efforts to mitigate the risk of failure to correctly operate the device, including, but not limited to, documentation of an appropriate end user initial training program on the proper spacer deployment technique.
(3) The device labeling must include the following:
(i) A detailed summary of reported or observed complications related to the use of the device;
(ii) Appropriate warnings;
(iii) Detailed instructions for system preparations and detailed implant procedure instructions; and
(iv) An expiration date that is supported by performance data as specified in paragraph (b)(1)(vi) of this section.
[83 FR 601, Jan. 5, 2018]
(a) Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.
(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.
(a) Identification. A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.
(a) Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.
(a) Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.
(a) Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(a) Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(a) Identification. A therapeutic x-ray tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing intended for use in radiation therapy. This generic type of device may include high-voltage and filament transformers or other appropriate components when contained in radiation-shielded housing.
(a) Identification. A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.
[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 65 FR 2323, Jan. 14, 2000]


text:
The Daily Show Tears Apart Sexist Catcalls in Glorious Fashion
Night Editor
On Tuesday night, The Daily Show dived head first into the great catcalling debate, with spectacular results.
Open media.mtvnservices.com
In the video above, Jon Stewart presents his usual masterful dismantling of the Bullshit of the Day (among other things, the utterly DUMB responses to Sen. Kirsten Gillibrand's revelations of being harassed by hideous fellow senators). He even tackles the nauseating display of cluelessness the women on Fox News displayed in response to all that.
Skeevy Senators Called Sen. Kirsten Gillibrand 'Porky,' Felt Her Up
Senator Kirsten Gillibrand was sexually harassed by another unnamed senator who, according to her…
But it's not until Jessica Williams, master of the campus rape denier takedown, gets her moment on camera do we really get the heartiest "fuck you" imaginable. (WARNING: SO MUCH AWESOMENESS IN THE CLIP BELOW)
The Daily Show's Take on Sexual Assault Is Devastatingly Good
How good is it? It's got everything a lady could want: Jessica Williams in top form. Jon Stewart…
"It means that the woman is trying her best to end this interaction, because if she doesn't smile, he might tell her to smile. If she tells him to leave her alone, he'll probably call her a bitch. And I know that he thinks he's different—that he's classy, he's charming—but, since going to work isn't a performance, we're not looking for applause. And what he's doing is basically just a high-minded Lincoln Center version of 'hey, sweet tits."
GODDAMNIT. I would stand up and cheer for this on every street corner right now, (just like all the people in the Daily Show audience did after this part of her bit) if I wasn't drowning in my own tears. That's the exact summation of how I feel when I see someone like Williams and the Daily Show writers so succinctly make this point on national television. I'm overwhelmed by watching a woman get a platform of this size to call out something that many of us feel is an issue which continually keeps getting brushed aside.
But while I revel in the sheer awesomeness of this smackdown, sadly, I know the reality is that it's probably not going to stop the next assclown from making a rude, vulgar or downright terrifying declaration of where he would like to put his penis/tongue/hands to whatever woman happens to be in his path. My only hope is that while a segment like this might not dissuade the average dudebro from unleashing his particular brand of sexist bullshit on unsuspecting women, it might serve to empower the next woman who is a victim of this crap. There's something powerfully liberating in knowing that not only aren't you alone in enduring this kind of abuse, but that others are speaking out—and speaking loudly—about just how wrong it is.


General Contact E-Mail: info@innogames.com – No game support, contact only in English or German please.
For game support and other game-related inquiries, please contact: Support.
The European Commission opened its new online dispute resolution (ODR) platform for alternative dispute resolution between consumers and online traders. Go to: http://ec.europa.eu/consumers/odr. You can reach us via the ODR. Normally, we will then contact you directly because we are not obliged to take part in a dispute resolution procedure in front of a consumer arbitration body.


The Accounting and Corporate Regulatory Authority of Singapore (ACRA) requires that all Singapore incorporated companies must file their annual financial report in the format of XBRL, an XML based business language. XBRL filing was introduced in Singapore in 2007 with an aim to improve regulatory compliance and enhance transparency.
XBRL stands for eXtensible Business Report Language, is a XML based language that use for preparing financial statement online in order to enhance worldwide business communication among business organizations and government bodies. With effect from 1st November 2007, ACRA (Accounting and Corporate Regulatory Authority) of Singapore had implemented XBRL filing as the new filing requirement for all Singapore companies unless the organization is exempted from filing. Through XBRL filing, financial data can be retrieved from online records and transferred directly to users such as financial analysts, auditors and regulators for various purposes.
Why to file in XBRL format?
XBRL filing facilitates a conductive business environment as it improves regulatory compliance and adds more value to financial information with enhanced transparency and timely dissemination of relevant financial data. Currently, companies are filing their XBRL report through FS Manager but it will be replaced by BizFinx offline tool with the implementation of revised XBRL filing requirement which will take effect from 2nd December 2013.
Which companies are exempted from XBRL filing?
All these exempted companies are allowed to file their financial statements in PDF format as tabled at or used for the purposes of their Annual General Meeting (AGM). Solvent and dormant EPCs (Exempt Private Companies) do not required to file their FS with ACRA.
Currently there are two options are available for XBRL filing. Option A is full set of XBRL filing and option B is partial XBRL. A full set of annual financial statement is filed using FS Manager whereas a partial annual financial report is filed using both FS manger and a PDF copy of its full set of financial statements.
In June 2013, ACRA has announced few new changes to XBRL filing requirement as per the new expanded ACRA Taxonomy 2013 which will take effect from 2nd December 2013. Under the revised XBRL filing requirements, all Singapore incorporated companies which are either limited or unlimited by shares are required to file their annual financial statements in XBRL format with ACRA. Filing of option B will no longer be available.
BizFinx, a new offline preparation tool will replace the current FS Manager with effect from 30 November. This new software application will enable the users to prepare financial report even in offline mode which was not available in FS Manager. Upon preparation, user can submit the file online via BizFinx portal subsequently.
Commercial and merchant banks, or insurance companies and finance companies that are regulated by the Monetary Authority of Singapore and companies allowed by law to prepare accounts in accordance with accounting standards other than SFRS, SFRS for Small Entities and IFRS will file AGM financial reports in PDF format with Financial Statements Highlights in XBRL format.
Companies limited by guarantee will continue to file their financial statements in PDF format to ACRA.
All solvent and dormant Exempt Private Limited Companies, will continue to be exempted from filing their annual financial report.
Why to outsource your XBRL needs with us?
Preparing your annual financial statement can be a time consuming and daunting task. Directors of the companies will be responsible for the correctness and accuracy of XBRL filing with ACRA. Thereby, it is advisable to take assistance of professional service in order to prevent the possibilities of errors and mistakes. SINGAPORE TAXATION is one of the renowned XBRL report service provider in Singapore who can deliver timely and compliant XBRL report and filing with 100% accuracy. Our dedicated experts are well aware of the latest regulations of ACRA especially about new amendments made in revised XBRL filing requirements. They even provide consultation to ensure that all your XBRL needs are fulfilled.


What are your clues? Do the graphics support text information or do they stand alone? A good composed article critique example APA will gradually decrease chances of making typical mistakes.
However, a fair assessment of any text, object, place or experience deeply analyzes all component parts and then renders judgment. In most cases you will be asked to perform your critique assignment using APA formatting. The APA article critique style is accepted by a number of universities.
What clues define the audiences? Many institutions provide such services to the public. What general observations can you make about the usefulness and value of the information you found on the Internet while aware of the fact that you have not covered all possible sites - only a sampling in your chosen field of study?
What effect did this help the author achieve? How do the various links relate to the main theme? What did you learn about the importance of critiquing sources, We b and non Web based, with a critical eye? Does it have a particular political or social agenda?
All of these things fit should fit into your critique because they determine whether or not the book was able to accomplish its goal. This helps you see how each of your ideas are connected and how every idea contributes to the understanding of another—moreover, it allows you to gauge how well the order of your ideas complements your thesis statement.
Peruse this sample article critique thoroughly to understand the structure and the points to be covered in an article critique.
Attune yourself to clues to help you recognize the true nature and intent of sites, and the reliability of the information.
Or the presentation may be an oral l report to the class, with the web page transmitted on a screen, using a Web browser. Instead, use the summary to explain the most important ideas the author tried to convey in the entire work and any other literary details that might guide or enlighten your reader.
This will make it much easier for you to write a quality critique essay on your book of choice. It can be found by every search engine within 5 minutes and couple of mouse clicks. For example is the Web page an advertisement for a product or service?The Critique Essay It's your first essay in ENGand, of course, you want to do well.
This handout offers some helpful hints for writing the first essay—The Critique. Research Critique of Qualitative Research on Registered Nurses.
Print Reference this. Published: 23rd March, Disclaimer: This essay has been submitted by a student. This is not an example of the work written by our professional essay writers. but have a non-partisan author as well to provide balance and a wider perspective.
At motorcarsintinc.com you will find a wide variety of top-notch essay and term paper samples on any possible topics absolutely for free. Want to add some juice to your work? No problem! Writing an article critique is an in-depth analysis of the article, evaluating its success in conveying the objective of the article.
Finding an Article Critique Example. When you are browsing the Internet for a critique example, whether it's a journal article critique example or a literary critique essay sample, you should keep in.
Locate a non web-based source dealing with stress. This resource might be a book, video, or audio from the library or a bookstore. Also, it could be a stress-related support group. There may be other sources.
Based on your chosen resource, develop a critique of approximately words, which, at a minimum, includes the following:. Written Assignment 1: Critique of Non-Web Based Stress Reduction Techniques Locate a non web-based source dealing with stress.
This resource might be a .


Submission for films is closed.
By the 15th of January, 2019, filmmakers of selected films will be notified personally. Due to the high number of applications the festival's programme committee keeps the right to notify only the selected works.
EUROPEAN DEBUT COMPETITION for films from Europe Countries (1st feature film).
Sunny statue for the Best Actor and 1000 Euro.
SHORT COMPETITION for short films from Europe Countries.
Best Short Film Award, Sunny statue and 3,000 Eur for the director of the winning film.
STUDENT FILM COMPETITION for short films created by Lithuanian students studying filmmaking in Lithuania or Abroad.
Best Student Film Award, 1,000 EUR for the director of the winning film.
24th VIFF Kino pavasaris will be held in March 21st – April 4th, 2019!
submissions@kinopavasaris.lt, mante@kinopavasaris.lt or 00370 680 36577.


As of this article the market as corrected a little over 500 points on the Dow. Roughly about a 4% correction. Primarily because of Federal Reserve tapering rumors. Volatility has increased, but is no where near the 2008 Credit Crisis levels, or even historic averages.
I've also noticed the conversations have changed by the media. They are constantly discussing the Fed's tapering timing, and guessing at what will happen next.
With the economy barely limping along at under 2% growth, some are questioning if we are truly moving ahead.
So is it time to get nervous?
1. Low inflation. Inflations is well below it's historic 3-3.5%. Somewhere around 1.4% as of this article. So goods and services are not getting more expensive.
2. Earnings are good. Company earnings are good for 2013 and are expected to grow this year and into 2014. So even if stock prices are down, this is a good long-term signal. It means companies are healthy.
4. Rising rates signal strength in the economy. Even though the Fed will end its stimulus program at some point, its because the economy has shown signs of serious improvement. So this is a classic problem of can't see the forest for the trees. Too much focus on stimulus and not on what the stimulus has accomplished.
Are there things to be worried about? Absolutely. However, I think there are too many extremes when it comes to just seeing positives or negatives. I try to see both sides of it, and still keep a bullish attitude about the economy's future.
If you are truly nervous about where we are, why not write me at david@lexwealth.com, or call me at 859-225-2596 to review your situation. Why not get better educated about the markets by subscribing to The Diligent Advisor by clicking here. It's FREE!


text:
Home Site Map Most popular articles aide auteurs
Cities, Regions and Territories
Additional index
Epistemological Foundations
Neolithisation
Anthropization
Marine current
maritime character
English > Society and environment > Additional index > Estuary
Traduction/Translation/Traducción
Also in this section Environments and Development Costs Altitudinal zonation Volcano Protected area Delta Marine current Mountain Beach
By the same authors
Christian Grataloup
1. An estuary is an area where a watercourse meets the water surface into which it flows, generally at the point where the river reaches the sea (or possibly a lake). Traditionally, all the forms of transition between watercourse and sea have been called 'mouths'; two types are distinguished among them: the delta and the estuary (making up one of the typical pairs found in school vocabulary: river/tributary, plain/plateau, etc.). The term delta is used when the accumulation of alluvium predominates, leaving a broad, low alluvial plain with a river, ramified into branches, flowing across it, often punctuated by lakes and lagoons. When the river course remains clearly perceptible, however, even in places where the valley becomes broader and the influence of the tides can be observed, the term estuary is generally used. But in addition to the fact that when the natural features are analysed, the distinction is not always clear (there are undersea deltas at the bottom of estuaries, estuaries with several branches, others that are bordered by maritime marshes, etc.), opposing the two forms ignores the essential reality: the place of contact between a river course (and hence a valley) and a space of open water, lake, sea or ocean, may represent a situation of transhipment, where there is a concentration of activities.
2. The estuary is a primary type of synapse, between land and sea, and as such, is a natural location for a harbour. Strictly speaking, in the past, and still today, the natural constraints in estuaries have been more favourable to boat traffic than those in deltas, which explains how the notion of the place of contact between an inland space drained by a river valley and a maritime space of exchange makes preferential use of this term. This represents a shift from a definition according to the natural environment (a non-delta type of mouth) to a meaning belonging mainly to the economic and social field. Indeed an estuary, with the help of the tide, allows sea boats, to penetrate, sometimes quite far, into the land. Landward ends of the estuaries of watercourses that move through dense hinterlands are classical locations for harbours (London, Buenos Aires, Rostov, Hamburg, etc.). If one carries this broadening of the meaning further, any mouth becomes an estuary: Rotterdam, which is on a false delta (in the sense of a natural environment, like the environments of the Ganges or of the Pearl River), but is at the opening of a true major economic valley, and even Fos-Marseille, which cannot be conceived otherwise than at the end of the Rhone valley, would then belong to the spatial category of the estuary.
The estuary space is generally marked by a downstream movement of harbour developments. The presence of a considerable population linked to those activities also generates other uses of the estuary banks or the immediate coastline (seaside resorts). It is easy to model the recurrence of such uses of estuary space. The general estuary chorotype (R. Brunet) is coordinated with more regional formalisations (M. Brocard).
In a world where maritime exchanges are becoming more and more important, where broad valleys represent increasingly congested axes, where peri-urban coastlines are more and more contested, it should come as no surprise that some of the largest cities in the World (Shanghai, Rangoon, Calcutta, London, New York, etc.) are located at the mouths of rivers.
3. Because of their very recent character (Flandrian transgression) and the interpenetration of marine and hydro-continental features, estuaries represent unstable, rich and vulnerable natural environments. Management of these complex environments is made all the more necessary and difficult by the fact that they represent preferred sites for major economic activities. Tensions between the pressures presented by the economic importance of a location and the natural particularities of the site may produce significant conflicts over uses. Estuaries are characterised by the alternation and mix of fresh inland waters and salted marine waters and their loads: the invasion of marine water during high tide (the incoming tide), which can be spectacular (a tidal bore), and the outflow of river water during low tide (ebb tide). Thus every day, in time and space, complex variations occur in the degree of salinity, in currents, and in processes of deposit/erosion. In particular, this context favours the landing of solid loads and the flocculation of colloidal murky suspensions (formation of mud blocks), as well as the frequent movement of these deposits (bars). This silting requires frequent dredging for the maintenance of boat traffic. Such environments are rich in biotic potentialities. Their diversity in the matter of flora and fauna is of course considerable. Like many amphibious environments, estuaries are also privileged stopping places for migratory birds. They are also essential places for the passage of those sea fishes that spawn in fresh water. This permanently intermediary character, this mixing between sea and land, causes us to exclude from the category of the estuary the lower part of valleys invaded by the sea, through which watercourses run with a very low rate of flow: these forms are designated as ria (or aber for a ria shaped as a funnel widely opening out onto the sea). Yet another term - liman - is used to designate a broad estuary that is almost totally closed by a sandy spit, and is thus an intermediary form between lagoon and estuary.
In a world where the coasts and valleys of densely populated countries are raising increasingly important spatial issues, it is not surprising that estuaries, which provide connections between them, are of vital importance.
See also: coast, maritime character
© Hypergéo 2014 - GDR Libergéo - - Powered by - Log in - Comité de Lecture - RSS 2.0


I have done this bulletin board off and on for over 20 years! The kids love it, even if they don't like bugs! The original bulletin board graphics that I usually use, are not sold any more. So, I decided to use the graphics from www.ScrappinDoodles.com to print new and make it available for you to make.
I also purchased 2 bug catchers at Dollar Tree, as you can see on the left side. I just stapled right through the netting and they are staying up!
You can use the bugs that I have included in the download, or you can purchase some that you like to save the printing & cutting. The big key for this bulletin board is the plastic bugs that I purchase and staple to the board. They really make everything pop and is more fun for the kids. I purchase my bugs at Dollar Tree, but you can find them at several stores.
You can print the title here.
You can print the kids and bugs here.
I printed the butterflies and added the kids names on the bodies. The kids love their names and/or pictures on the bulletin boards! You can print the butterflies here.


text:
Stocks making the biggest moves in the premarket: Deere, Alibaba, Foot Locker, Lululemon & more
Take a look at some of the biggest movers in the premarket:
Deere (DE) – The construction equipment maker reported fiscal second-quarter earnings of $2.11 per share, compared to the consensus estimate of $1.62 a share. Revenue beat estimates as well. Deere said it expects global equipment sales to fall 30% to 40% this year as the Covid-19 pandemic weighs on demand.
Alibaba (BABA) – The China-based e-commerce giant beat estimates on both the top and bottom lines for its fiscal fourth quarter, and topped $1 trillion in gross merchandise volume for the first time in the just-concluded fiscal year. Alibaba benefited from an increase in online shopping due to the coronavirus outbreak.
Foot Locker (FL) – Foot Locker lost 67 cents per share for its latest quarter, wider than the 25 cents a share loss that Wall Street was expecting. The athletic footwear and apparel retailer's revenue also missed estimates, with comparable sales plunging a wider-than-expected 42.8%. Foot Locker has also temporarily suspended its quarterly dividend.
Lululemon (LULU) – Lululemon said it has reopened more than 150 of its retail locations, with the athletic apparel maker planning to reopen about 200 more stores over the next two weeks. It has instituted a new set of reopening guidelines, including enhanced cleaning, modified hours, and limits to the number of customers in a store at any one time.
Palo Alto Networks (PANW) – Palo Alto reported quarterly earnings of $1.17 per share, compared to a consensus estimate of 94 cents a share. The cybersecurity company's revenue also beat Wall Street forecasts, and it said it will benefit from a continued increase in remote working.
Nvidia (NVDA) – Nvidia beat estimates by 11 cents a share, with quarterly earnings of $1.80 per share. The graphics chipmaker's revenue also beat forecasts. Nvidia gave an upbeat forecast, on surging demand for its chips that are used in data centers.
Hewlett Packard Enterprise (HPE) – Hewlett Packard Enterprise fell 7 cents a share short of estimates, with quarterly earnings of 22 cents per share. The enterprise cloud computing company's revenue also fell short, with HPE's business impacted significantly by the coronavirus outbreak. The company also unveiled a cost-cutting plan designed to save at least $1 billion by 2022.
Alphabet (GOOGL) – Proxy adviser ISS recommended that shareholders vote against executive pay proposals at the Google parent's annual meeting in June. ISS criticized the proposals as "outsized awards that are not sufficiently performance-based."
Splunk (SPLK) – Splunk reported a quarterly loss of 56 cents per share, a penny a share smaller than Wall Street had expected. Revenue came in short of forecasts, but the maker of data analytics software said it expected stronger demand for its cloud services as more people shift to working from home.
IBM (IBM) – IBM will cut an unspecified number of jobs, the first workforce reduction under new CEO Arvind Krishna, who took over from Ginni Rometty earlier this year. A person familiar with IBM's plans told The Wall Street Journal that several thousand workers are likely to be affected.
e.l.f. Beauty (ELF) – The company doubled Wall Street expectations with quarterly earnings of 10 cents per share. The cosmetics retailer's revenue also topped estimates. The company said the pandemic has impacted its sales, and it expects continued negative impact until consumers return to normal shopping patterns.
Ross Stores (ROST) – Ross Stores reported a quarterly loss of 87 cents per share, surprising analysts who had expected a profit of 3 cents per share. The discount retailer's revenue also fell short of estimates as the coronavirus outbreak forced it to close stores, but Ross did say it began reopening stores last week.
Deckers (DECK) – Deckers earned 57 cents per share for its fiscal fourth quarter, well above the 9 cents a share consensus estimate. The maker of UGG boots and Teva sandals posted revenue that came in above forecasts, although it said it is facing challenges due to virus-related store shutdowns. Deckers is not providing guidance for the current fiscal year due to uncertainty surround the pandemic's impact.
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There are already tons of editorials, research, market studies, and opinions about the relations between hotels and online travel agents, very often called the battle for direct bookings. The problem has been analyzed from many different perspectives, and even if the final theses are sometimes inconsistent, the whole industry agrees that no hotelier is winning this competition.
To better understand the background, lets go back to the mid-90s when most of the big OTAs were starting their quest for the share of the online travel market. If we were to ask hoteliers who were already operational in those days, not many could confirm that a hotel website was customary. By website I do not mean the sites from those days even remotely resemble modern ones. Back then the typical site was nothing more than a static landing page under a hotels domain. At the beginning of the 2000s, the first providers of booking engines entered the market a sign that the hospitality industry was looking fervently at direct distribution. At a time when booking.nl was already on the market for ten years, offering a customer friendly business model based on commissions, hoteliers began catching up with OTAs. In comparison to the merchant system, this was a dream for most of the hoteliers who could pay a percentage of the selling price, AFTER the business was delivered.
Despite that fact, more and more technology companies were entering hotel industry offering their reservation engines, at the same time educating the market.
This process is still on as hoteliers do not ask anymore if they should have the booking engine, but which booking engine will work best for them.
As Martin Soler puts it, direct revenue has unfortunately become a way to get attention in the hotel marketing world. The problem with such buzzwords being used and abused is that in the long run they sound like conspiracy theories. All one needs to do it say the words and suddenly they are no longer credible. There is inherent value in retaining control and a fair share of direct bookings. The most recent debate if hotels should obsess about direct or not is splitting hairs. Hoteliers should obsess about having a healthy distribution mix. That means a fair share of direct, OTAs, and other channels.
Healthy distribution mix a concept forgotten by many, and while I could understand that independent hoteliers, with limited resources, staff and know-how could miss the point, its interesting to see, how painful this mistake was (is) for big players.
A few years back we saw the attempts of almost all big hotel companies to shift the pattern from 3rd party channels to direct. We all have heard all those brave declarations about massive investments in technology and marketing to win back the control. Moreover, we also see that not many of them were successful. Its a very sensitive topic, as one of the most significant values hotel owners are paying for to hotel brands is the distribution.
A few decades ago brands were the power of distribution. Branded hotels had an incredible distribution advantage over non-branded hotels. Branding a hotel was like plugging into a power line. Distribution systems were hardly known. Today things are quite different, travelers are more aware of distributors (the pipes) than the brands, adds Soler.
Why is it so important to deal directly with the customer/ guest? For sure because of the costs, which are rising without any control from the suppliers side. Moreover, data, big data about guests habits, expectations, behaviors- anything that happens before and during the booking process, which ends with the reservation.
Are all the faults on the side of the OTAs who misuse their power over hoteliers? Could hoteliers do anything better? When OTA brings the new customer to the hotel and charges the commission, I see it as a fair deal, as most probably a hotelier would not be able to acquire new guest for the same amount. However, if the customer already knows the hotel, likes the brand but still books through the OTA (generating commission cost) whos fault is it?
Coming back to the present times Artificial Intelligence becomes a commodity, chatbots are taking our reservations and we check-in with face recognition solutions. The tourism industry is booming thanks to the healthy global economy, fueled by Chinese travelers, who are more and more eager to travel the world and spend their yuans. However, when talking to hoteliers about the development of the Chinese market, I feel like 15-20 years ago, while discussing the importance of online presence for hotels.
Most of the inventory of European hotels sold to China is based on traditional B2B agreements with travel agents so primarily offline. Those rooms are later on loaded to Chinese reservation portals and marketplaces, but they are already out of the control of the hotelier. Everything a hotelier can see at this point is the reservation with the name of the guest, very often even without direct contact data - either phone or email.
The situation with the Chinese market is even more complicated, as simple placement on the Chinese OTA needs a lot of effort and patience, mainly due to, lack of local support and the language barrier. On top of this hoteliers also face the connectivity issue, as not all Channel managers/ PMSs support Chinese channels.
Take heed, the situation is not so hopeless. Elijah Whaley, CMO of influencers marketing agency PARKLU, explains we are finally starting to see an increase in long-term commitments between (hotel) brands and social media influencers. Long-term sponsorship relationships allow brands to become more synonymous with an influencer in the eyes of followers. Brands that negotiate long-term contracts often use influencers for promotion and as content creators for branded channels.
Ultimately, its about finding novel ways to connect with customers while staying top of mind with quality social content.
Most hoteliers still give away low pricing, brand, and guest relations. Even when there is coming to a group of Chinese travelers, they come and go without proper interaction with the hotel, either offline or online.
Building a brand in China is even more difficult due to the language barrier, separated digital ecosystem, and entirely different applications.
Complexity and level of complication make the whole attempt more expensive. However, do hoteliers want to give up the entire brand to third parties, like we used to see some time ago and then fight back? One would say, that Chinese market is currently just a few percents of their business- sure, but take into consideration the fact that its only 5-7% of Chinese who own the passport and just a fraction of it comes to Europe. What is the situation going to be, when the passport is held by 40% of the population (as in case of Americans) or 76% (like Britons) and they will like to travel to Europe more? Based on the UNWTO research, by 2030 China will account for almost a quarter of international tourism. What then? Is your hotel ready to forfeit 25% of the business and give it out to third partiesagain? Alternatively, should you instead learn the lesson and at least try to find out what are the chances to build your brand in China? What are the possibilities? How much could it cost? What tools are available on the market? And so on.
One of the ways to answer all these questions is participation in industry events, and the next opportunity comes in January, when the conference Marketing to China takes place in Prague. Why is it worth to go there?
plus the representatives of the agencies, which successfully marketed to China brands such as: Hilton, Nike, Starbucks, Disneyland, City of Paris, Leading Hotels of the World, Air Canada and many more.
HO[S]TELOFFER.ONLINE offers sales process software for hotels and hostels. The company is based in Berlin, Germany and it's 100% owned by its Founder, Tomasz Janczak. HO[S]TELOFFER.ONLINE software product is a cloud-based Saas solution, easy to implement, and affordable even for mid-market players.
Tomasz Janczak began his career in late 90's, being responsible for Business Development of western technology companies in the region of Central Europe. After joining Avvio in 2009 as Director of Sales Central Eastern Europe he ignited the development of this brand in the Region. In 2011 he became Corporate E-Commerce Director at Mamaison Hotels& Residences where his main responsibility was the development and implementation of the e-commerce strategy and brand reputation management at group level.


Weddings are very momentous for the new couple, as well as their loved ones. Lots of folks assume that a great deal of money is necessary for a great wedding, but they are wrong. You can have a beautiful wedding without breaking the bank. All it takes is a little inspiration, a few ingenious measures, and the ability to do so without sending yourself to the poorhouse.
Use the property of a relative or friend to hold your wedding. Using someone else's property can free a huge expense from off your plate and allow you to allocate funds elsewhere. Offer to pay people to come into the place ahead of time to do some cleaning and then after the event, and that will be the only costs.
When you are looking for a wedding makeup artist, look at examples of what has been done for other clients. Are you comfortable with the makeup they've done before? So choose a makeup artist carefully and consider having them do your makeup in a test session weeks before the wedding. It would be terrible to have the artist do your makeup only to realize you are unhappy with it.
Try ethnic-themed catering to add some spice to your reception. Chicken and steak have been done to death, so you may want to branch out a little. Variety should be incorporated into your wedding dinner to make it a memorable experience.
Incorporate small decorative elements into all your wedding decorations. Whether it is a certain color used, or a special flower or even a special item such as doves, special touches help pull everything all together. Your wedding will be perfect when you add in the small details.
Instead of spending a fortune on a wedding cake, get a bunch of mini-tarts or cupcakes. Many people like these sorts of arrangements because they are convenient, versatile and affordable. Guests can simply pick up a cupcake or two as they leave, placing them in a takeout-inspired, embellished cardboard container.
You should put a great deal of thought into writing your wedding vows. It's important to understand that a marriage is a strong commitment that takes both of you making sacrifices. Express your unconditional love for your future spouse in your vows.
Invite the whole family to the honeymoon when you're planning a destination wedding. Longer stays at hotels are often discounted so it'll save you money in the long run. This will give them a day to remember and a vacation of their dreams, too!
Think about your guests when planning flower arrangements for the reception. Often, flowers interfere with guests being able to converse across the table. Not only that, but you may have some guests who are allergic to flowers. Consider placing non scented candles on the table for a romantic look.
While it's important to provide your wedding DJ with a list of songs you love and wish to be played at your reception, it's equally as important to let him know what you DON'T like. Make the list of music to be avoided with your partner. Just let him know beforehand so you don't have any sad moments at your wedding.
If you conduct your wedding in a vacation spot, have a basketful of themed goodies delivered to each guest's room. Have items in them like disposable cameras, hats, sunglasses and tourist maps of the exciting places that they can visit. Also make sure you include a local restaurant guide that makes it simple for them to grab a bite to eat.
If you're a bride that's passionate about fashion and luxury, you can add some pizzazz to your bouquet with crystals, rhinestones, or even diamonds. Add heat-fixed crystals or adhesive ones to your bouquet, or tie a piece of jewelery to it. Use stones that are roughly the same cut, size, and color as those in your ensemble to ensure coordination.
Don't take your dress home right after buying it. It could get stained or wrinkled in your closet. Keeping it safely at the shop will ensure that it is in pristine condition and ready for your wedding day.
If it is within your budget, you might want to take a wedding cruise with just your closest friends and family. The wedding itself will almost feel like the honeymoon. Many cruise companies have special deals for wedding and honeymooning couples.
Table centerpieces for your wedding can be very costly, both financially and in terms of aesthetics. Rather than spending a fortune on centerpieces that are almost as big as the tables themselves, keep them small and simple. You will then allow people to have a conversation without unnecessary distractions; this will bring your guests closer.
As an example, why not try a fusion menu with contemporary dishes that everyone enjoys? Include ethnic options for dessert, drinks, or even wedding favors that are edible.
Get more out of your wedding planner with research done ahead of time. You can create a board with different books, fabrics, and elements that you want to incorporate into your wedding. Make use of clippings from magazines, photos and even lyrics from songs to get your vision across.
Your caterer needs to know if you are planning on having a reception outdoors. Some food are unsuitable for outdoor receptions, as they will spoil in 90 degree heat or blow around in the wind. Fancy serving dishes, with covers, might be an option. If needed, you can keep beverages cool in a small fridge.
Find a wedding day photographer who is able to capture memories. Ask a photographer for thoughts on your big day when interviewing them. Inquire about the way in which they participate in each aspect of the day. You should understand their process and how they will impact your big day.
A gift registry is often common with weddings. To ensure a more pleasant event, make sure your guests know that a gift is not a requirement. Give them multiple options for gifts and a very wide price range. Your guests should feel that their gifts, no matter how modest, are welcomed and appreciated.
Add depth to your floral decor and centerpieces by incorporating floral elements of different heights. For long stem flowers, use tall vases. Inside the taller vases, to keep them from looking bare, you should use full arrangements to fill in the gaps around the opening. The short and full flowers should be a few shades lighter than the taller blooms that are more prominent.
Make your floral arrangements more complex by incorporating different heights. Use tall vases for flowers with longer stems and more compact heads. You can then surround the vases using flowers with more show and volume but that are shorter. Have the shorter flowers be lighter in hue than the taller blooms.
When planning your wedding, decide if you would like any children to attend. Not allowing children may reduce headaches and costs. On the other hand, some people might not be able to come if you don't let their children come with.
Carefully plan out activities that will entertain your guests. This is a wonderful change to having your guests simply loitering around between the nuptials and reception. You can plan any number of fun games, from wedding couple trivia to musical chairs. Your wedding will be a more memorable event when everyone has fun and interacts with each other.
The earlier you start your wedding preparations, the better. The earlier you plan, the more options you will have open to you. This makes it possible for you to choose the vendors who best meet your needs.
Compose your very own wedding vows. You know your spouse better than anyone else. Writing your vows will make your future spouse feel more special and will make your wedding more meaningful and romantic. You can use other sources for inspiration and build your own touches into them.
Apply for a credit card that has a rewards program before paying for event services. This way, you are sure to gain some significant perks while taking care of the large expenses that come with weddings. Stick to one credit card for all your wedding purchases, so you can get lots of rewards.
Ask vendors you're already using to recommend other services you need. Once you have picked the right photographer, have them suggest a band or DJ they may like. Then ask the band for a recommendation for another service. People who work weddings frequently in one capacity or another are bound to have inside information.
You can get great recommendations from the other services you hire. If you find a photographer that you love, ask that person to recommend a band that they like. Experienced photographers or others in the wedding business are likely to know great sources for flowers, bands, and other things you will need for your wedding. Not only does this make the search much easier, these recommendations are often made because they do good work. Those that told you about them are not going to want their reputation hurt by someone who offers poor service off of their recomendation.
What bridesmaid or maid of honor wouldn't be delighted to receive personalized jewelry as a token of your appreciation? That way, the bridesmaids will all be able to relive the special moment forever.