ELK LASER IMAGER, MODEL EL-DRY 4000

{0}------------------------------------------------ ## 510(k) Summary ### 1. Company Identification K011949 #### Elk Corporation 2-17-4 Yushima Bunkyo, Tokyo, Japan Tel. (03) 3818-1324 Fax (03) 3818-1814 e-mail elkint@ca.mbn.or.jb ### 2. Official Correspondent Gary J. Allsebrook, Consultant Regulatory Management Services 16303 Panoramic Way San Leandro CA 94578-1116 Tel: 510-276-2648 Fax: 510-276-3559 Email: regman1@home.com #### 3. Date of Submission June 19, 2001 #### 4. Device Name | Classification Name: | Medical Image Hard Copy Devices were evaluated<br>by the Radiology panel and are classified in Class I<br>per 21 CFR §892.2040. ProCode LMC | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Laser Imager & Video Capture | | Proprietary Name: | Elk Laser Imager, Model EL-DRY 4000 | #### 5. Substantial Equivalence Kodak DryView 8100, 510(k) number unknown ### 6. Device Description and Intended Use The EL-DRY 4000 is a desk top radiographic Laser Imager. The EL-DRY 4000 The EL-DN I - 1000 10 a deen top edical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. Digitized image data is processed to match the film size mcall of semiconductor laser 22gitLed . and formats (1,2,4,6,9,12,15,16, 20, 24), and these processed data converted into laser out put. Three different image-processing l {1}------------------------------------------------ methods are available; selection is made via the imaging pad. This system is controlled by a micro-processor, and all parameters can be set using the imaging pad. Furthermore, necessary information such as format, system status, and error indicators are all shown on an LCD readout. In addition, 15 types of LUT (characteristic of film density levels) settings are available; selection is also made using the imaging pad. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images. #### 7. Software Elk Corporation certifies that the EL-DRY 4000 software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. #### 8. Hazard Analysis Hazard analysis on this product has been performed throughout the definition, design, coding and testing phases of product development and implementation. This process has emphasized: - . Identification of potential hazards, their causes, and their effects; - . Development of methodologies to control the occurrence of hazards and to constrain their effects; and - . Determine any effect on patient safety and system effectiveness. The potential hazards associated with this software product are no different than those of other PACS components . These are primarily related to failure of computer system components, and may be variously obviated by decisions taken by the customers of this product. None of these failures are expected to materially contribute to patient death or injury. It is our conclusion that there is no hardware or software component, operating in a properly configured environment, whose failure or latent design defect would be expected to result in death or injury of a patient. Thus the "Level of Concern" is "Minor". #### 9. Safety Concerns Standards Applied for: | USA | UL 2601 -1 | |--------|------------------| | Canada | CSA-C22.2 #601-1 | | E.U. | IEC 60101+A1+A2 | | | IEC 60825 | | | IEC 60601-2 | | | MDD ANNEX I | {2}------------------------------------------------ ## 10. Substantial Equivalence The following product provides functions, which are substantially equivalent to this product. | Specifications | Elk, EL-DRY 4000 | Kodak, DryView 8100 | |-----------------------|--------------------------------------------------------|----------------------------------------| | Exposure Method | Infra-Red Laser Diode | Infra-Red Laser Diode | | Film Type | Kodak DryView Film | Kodak DryView Film | | Film Size | 14"x17",14"x14" | 14"x17" | | Pixel Size | 80x80 micron | 80x80 micron | | Max. Number of Pixel | 4,444x5398 <14"x17"> | 4,361x5217 <14"x17"> | | Formats | 1,2,4,6,9,12,15,16,20,24 | 1,2,4,69,12,15,16,20 | | Interface | Video, Digital, DICOM<br><w/interface> | Video, Digital, DICOM<br><w/interface> | | Number of Inputs | Up to two | 1<Up to 3 with combination of<br>9410> | | Output Grayscale | 4,096 steps <12 bits> | 4,096 steps <12 bits> | | Image Memory | 64 MB <standard> SIMM | 2GB Hard Desk | | Contrast Table | 15 Tables | 15 Tables | | Interpolation | Replication, Bilinear,<br>High-resolution Cubic Spline | Sharp, Smooth | | Calibration | Automatic Calibration<br>by mean of Imaging Pad | Automatic Image Quality Control | | Magazine | 125 sheets <Darkroom loading> | 125 sheets <Day-light loading> | | Through put | 60 sheets / hour | 55 sheets / hour | | Power Source | 100-120/200-240VAC, 50/60Hz<br>10/5A | 100VAC, 50/60 Hz, 12A | | Dimensions<br><WxDxH> | 522x650x390mm | 635x660x1168mm | | Weight | 70kg | 188kg | 3 : : {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling an emblem. The emblem includes a stylized caduceus, a symbol often associated with medicine and healthcare, representing the department's focus on health-related matters. #### Public Health Service # AUG 2 9 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Elk Corporation % Mr. Gary J. Allsebrook Regulatory Affairs Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116 Re: K011949 Elk Laser Imager, Model EL-DRY 4000 Medical Image Hard Copy Device Dated: June 19, 2001 Received: June 21, 2001 Regulatory Class: II 21 CFR 892.2040/Procode: 90 LMC #### Dear Mr. Allsebrook: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is we nave reviews for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in commove prot to the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to ate general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 11 your de ro to to regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 07: 1 Satonalitant's System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic as so rollar in the Quand Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may Q nisponons, all 1 oda alla 2rdg Prail. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please result it response to your premarket notification does not affect any obligation you might have under sections 531 through note: and response to your promate Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4,xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ 510(k) Number (if known): Elk Corporation, Laser Imager, Model EL-DRY 4000 Device Name: Indications For Use: The EL-DRY 4000 digitizes image data output from medical imaging apparatus in the form of video or digital signals, then records this printing data onto the Kodak DryView laser film by mean of semiconductor laser. The intended use of the EL-DRY 4000 is to produce radiological quality film copies of digital or video medical images. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 901.109) OR Over-the-Counter Use Mamie C. Brooks (Optional Format 1-2-96) | (Division Sign-Off) | | |---------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K011949 |