DX-480, ADD ON DIGITAL IMAGER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a representation of human figures. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 20 1998 David Andres Official Correspondent Wuestec Medical, Inc. 421 Holcolmbe Ave. Mobile, AL 36606 K981880 Re: DX-480, Add on Digital Imager Dated: May 27, 1998 Received: May 28, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR Dear Mr. Andres: 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 requirements, 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 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 finternet address "http://www.fda.gov/cdr/dsmaldsmamain.html". Sincerely yours, William Yip Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {1}------------------------------------------------ ## INDICATIONS FOR USE K981880 510(k) Number: DX-480 Device Name: The DX-480 Imager Unit is a solid-state ( electronic ) x-ray acquisition device designed to replace film-cassettes used in conventional x-ray processes. The imager is designed to be mounted in a wide variety of positioning devices such as floating tables, swing-arm assemblies, and upright stands. David A. Sayre (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number Prescription Use (Per 21 CFR 801.109)