DIGITAL ADD-ON BUCKY

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 21 1997 Michael Baker CEO Swissary Information Solutions 5775 Soundview Drive, Suite 103A Gig Harbor, Washington 98335 Re: K970136 Swissary Telleray AG Digital Add-on Bucky System Dated: November 4, 1997 Received: November 5, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR Dear Mr. Baker: 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 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 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 QS 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 the 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 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,  Enclosure {1} Page 1 of 1 510(k) Number (if known): _________________________ Device Name: Patriot ## Indication For Use: The Swissray Telleray AG Digital Add-on Bucky system is a high resolution, digital imaging system designed for Digital Photofluorography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general Radiography and fluoroscopy procedures are performed. The Digital Add-on Bucky is intended for applying general radiography on a patient in a supine, seated, or standing position including tomography examinations. The Digital Add-on Bucky system allows the operator to view and enhance the images. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. The Add-on Bucky system enables the operator to hardcopy images with a laser printer. The major system components include: a CCD camera, monitors and an image processor. (PLEASE DO NOT WRITE BELLOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (DOE) Prescription Use ☑ OR Over-The Counter Use _________ (Per 21 CFR 801.109) (Optional Format 1-2-96) David H. Nyerson (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number R970136