KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)

{0}------------------------------------------------ # SUMMARY OF SAFETY AND EFFECTIVENESS #### INTRODUCTION I. The Kodak Digital Science 9000D Medical Laser Printer (MLP 9000D) is a secondary imaging device that receives data from various modalities that can be stored and then printed on film for evaluation by a radiologist. The MLP 9000D is an integrated system which is based on the overall system concept of the Kodak Ektascan 2180 Laser Printer (KELP 2180), Common Protocol (CP) interfaces and the Kodak X-Omat 180LP/LPS Processor system. The MLP 9000D's film transport and exposure mechanisms will be a modification of the current KELP 2180 design. The Kodak X-Omat 180LP/LPS will be replaced by a dry thermal processor that will be used to develop a new photothermographic film. The MLP 9000D will consist of many components which are similar to the KELP 2180. Examples are various input sections that are either video, digital, digital video, or network interfaces that interact between the host and the MLP 9000D to perform its tasks. The operator interfaces with the system by either using a keypad to store and print images or with an autofilming link to perform the same storing and printing functions at a system console. ### II. GENERAL INFORMATION Name of Manufacturer: Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester, New York 14653-5513 Establishment Registration Number: 1317307 Device Name: KODAK Digital Science 9000D Medical Laser Printer Device Classification: Class II Device UCT - 7 1997 {1}------------------------------------------------ #### III. THE DEVICE The general hardware configuration of the KODAK Digital Science 9000D Medical Laser Printer contains the following major components / subsystems: Modality Interfaces Laser Printing System Processor with optional Film Sorter #### OPTIONAL ACCESSORIES: Image Buffer Controller / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer High Capacity Image Buffer Disk / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer Memory Board / 6 MP / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer Seismic Kit / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer Standard Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer Basic Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer Enhanced Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical.Laser Printer and KODAK EKTASCAN 2180 Laser Printer High Capacity Enhanced Image Buffer / for KODAK DIGITAL SCIENCE 9000D Medical Laser Printer and KODAK EKTASCAN 2180 Laser Printer #### IV. INDICATION FOR USE Images printed on film from the Laser Printer will be used for primary diagnoses, similar to other laser printers and CRT multi-format cameras. Evaluation of the hard copy output by trained health care professionals provides adequate opportunity for competent human intervention. Laser printers are not represented to be of use in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury. 2 {2}------------------------------------------------ ## V. Comparison of features | IMAGING FEATURES | KELP 2180 | 9000 D | DV 8700 | |-----------------------|------------------------------------|-----------------------------------|-----------| | Laser Type | Red Diode | Red Diode | IR-Diode | | Deflection | Polygon | Polygon | Galvo | | xxxxScan | Scan Roller | Scan Roller | Galvo | | Image Matrix | 4096x5120 | 4096x5120 | 4096x5120 | | Bits/Pixel | 12/12 | 12/12 | 12/12 | | Trim Option | Yes | Yes | Yes | | Pixel Pitch (Microns) | 79 | 79 | 80 | | Laser Power | 5mw | 50mw | | | TONE SCALE FEATURES | | | | | Contrast | -5 to +5 | -5 to +5 | | | Density Max | 3.2 | 3.2 | | | Curve Shape | 6 | 6 | | | Interpolation | Cubic/Rep/<br>Sharp Cubic/Bilinear | Cubic/Rep<br>Sharp Cubic/Bilinear | Cubic/Rep | | PHYSICAL FEATURES | | | | | Footprint (in.) | 31 x 52 | 31 x 52 | 32 x 26 | | Kodak Processor | 180LP Wet | Thermal | Thermal | | Roomlight Film Supply | Yes | Yes | Yes | | Film Sizes | 4 | 4 | 1 | | PRODUCTIVITY | | | | | Lockout Time (sec) | 0 | 0 | 0 | | Cycle Time (sec) | 20 | 30 | 30 | | Print Time | 12 | 26 | | | Memory Capacity (MB) | 4G | 4G | 128MB | | Autoprint | Yes | Yes | Yes | | Random Erase | Yes | Yes | Yes | | MULTIPLE INPUTS | KELP 2180 | 9000 D | DV 8700 | | Max Inputs | 8 | 8 | 8 | | Volatile Memory | No | No | Yes | | Keypad/Autofilm | Yes | Yes | Yes | 3 {3}------------------------------------------------ #### VI. REGULATORY COMPLIANCE The Kodak Digital Science 9000D Medical Laser Printer (MLP 9000D) is being designed and tested in conformance with the following standards. Product Safety | EN 60601-1 | Medical Electrical Equipment, General Requirements | |---------------------|----------------------------------------------------------------------------------------------| | EN 60825 | Safety of Laser Products, Part 1: Equipment Classification,<br>Requirement, and User's Guide | | CSA C22.2 No. 601.1 | Medical Electrical Equipment, Part 1: General Requirements | | UL 2601-1 | Medical Electrical Equipment, General Requirements | | Laser safety: | Title 21CFR CHAPTER 1, /subchapter J, Part 1040.10 | #### Electromagnetic Interference EN 55011 Class B/1992, EN 50082-1/1992, EN 60950/1993 following the provisions of the applicable directives 89/336/EEC and amendments 72/23/EEC and amendments EN 61000-3-2 Power Line Harmonics EN 61000-3-3 Flicker Electromagnetic Noise Susceptibility EN 50082-1:92, Generic Immunity as tested per the following: (a) IEC 801-2:91; ESD, 4 KV direct, 8 KV air. (b) IEC 801-3:84; RF Immunity Severity Level 2. - (c) IEC 801-4:88; EFT Severity Level 2 #### Seismic Requirements of the State of California, Office of Statewide Health Planning and Development for "Pre-Approval" in accordance with California Administrative Code, Title 24, Part 2 and Title 22, Division 7, Chapter 7. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a symbol consisting of three stylized human figures. The figures are arranged in a vertical stack, with each figure represented by a simple, curved line. The overall design is clean and minimalist. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT - 7 1997 Robert L. Hiller Director, HI Regulatory Compliance Eastman Kodak Company Health Imaging Division 901 Elmgrove Road Rochester, NY 14653 K972847 Re: Kodak Digital Science 9000D Medical Laser Printer Dated: July 30, 1997 Received: August 1, 1997 Regulatory class: Unclassified Procode: 90 LMC Dear Mr. Hiller: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours. hDliau Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 510(k) Number (if known): _ K97284 Device Name: KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER INDICATION FOR USE: The KODAK Digital Science 9000D Medical Laser Printer is a laser printer designed to produce hard-copy films of digitized medical images. It is a newly designed printer to be added to Kodak's family of medical laser printer products that is intended for the centralized network printing solution for high volume sites for maximum productivity. This printer will be environmentally friendly by eliminating wet chemistry, site concerns, costs and will reduce chemical disposal problems. This is accomplished by using a totally proprietary imaging process. Images printed on film from the laser printer will be used for primary diagnosis, similar to other laser printers and CRT mult-format cameras. Evaluation of the hard copy output by trained health care professionals provides adequate opportunity for competent human intervention. Laser printers are not represented to be of use in supporting or sustaining human life, nor do they present a potential for unreasonable risk of illness or injury. Sincerely yours, Robert L. Hiller Robert L. Hiller 7/30/97 Robert L. Hiller Director, Regulatory Affairs KODAK Health Imaging (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 CRF 801.109) OR Over-the- (Division Sign-Off) Over-the-Counter Use (Optional Format 1-2-96) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number