CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three human profiles within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is printed to the right of the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP | | 1997 Re: Oscar Khutoryansky Vice President Trex Medical Corporation 2000 South 25th Avenue Broadview, Illinois 60153 K972442 Ceiling Mounted Lateral Positioner, Model No. 6896.002 Dated: June 25, 1997 Received: June 30, 1997 Regulatory class: II 21 CFR 892.1650/Procode: 90 JAA Dear Mr. Khutoryansky: We have reviewed your Section 510(k) notification of intent to market the device and we have determined the vice is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce rior 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 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 Ouality System Regulation (OS) 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 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 question 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, h Lillian Yiu, Ph.D. 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 {1}------------------------------------------------ S 10(k; Number (if known): K972442 Devic : Nami: Ceiling Monnted Lateral Positioner, Model No. 6896.002 Indications For Use: The Ceiling Mounted Lateral Positioners Model 6896.002 will be used for cardiac imaging required for electrophysiology and heart catherizations imaging Oscar Klunbonsky - VP (PLE \SE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David A. Bergman (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number Prescription Use Per :' I Cl R 801. 109) OR Over-The-Counter Use (Optional Formal 1-2-961