MXU-125 OR TMX-125

{0}------------------------------------------------ ## 510 (k) SUMMARY ## I GENERAL INFORMATION: Establishment - - Trex Medical Corporation Address : . LORAD Division 36 Apple Ridge Road Danbury, CT 06810 - Contact Person: Kelvin Burroughs ● Regulatory Affairs Telephone- 203 790 1188 Fax- 203 743 3370 Device Name - MXU-125 or TMX-125 Mobile X-ray Unit - 21 CFR Subchapter J II PERFORMANCE STANDARD: system components to which the above standard All applies are certified to conform to 21 CFR Subchapter J (21 CFR 1020.30, 1020.31 and 1020.32 Diagnostic Xray Equipment Standard) - SUBSTANTIAL EQUIVALENCE: III Mobile X-ray Unit has similar technological The characteristics and intended uses as the predicate devices below. TREX Medical Corp. believes the Mobile X-ray Unit is substantially equivalent to the following medical devices : | Model | Company | FDA 510 (k) | |---------|----------------------------|-------------| | RT-125 | Lorad Medical Systems Inc. | K894643 | | AMX - 3 | GE Medical Systems | K902610 | - III Indications for Use: The MXU-125 or TMX 125 is a Mobile x-ray Unit intended for use in general radiographic medical procedures by a licensed professional. {1}------------------------------------------------ ## TECHNOLOGICAL CHARACTERISTICS: IV The Mobile X-ray Unit is a portable, battery-powered, self-propelled - unit - designed - for - making - film radiographs in a hospital environment. The unit is capable of generating diagnostic x-rays according to the technique factor combinations selected and controlled by the operator. Unit complies with Part 1020, Performance The Standards for Ionizing Radiation Emitting Products and conforms to recognized voluntary standards for electrical safety, electromagnetic compatibility of medical equipment and radiation safety. {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 6 1999 Kelvin Burroughs Regulatory Affairs TREX Medical Corporation Lorad Division 36 Apple Ridge Road Danbury, Connecticut 06810 RE: K992229 MXU-125 or TMX-125 Mobile X-ray Unit Dated: June 29, 1999 Received: July 2, 1999 Regulatory Class: II 21 CFR 892.1720/Procode: 90 IZL Dear Mr. March: 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 legally marketed predicate 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). 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 (Special Controls) or dass 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 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/dsma/dsmamain.html". Sincerely yours, CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for TREX Medical Corporation. The word "TREX" is in large, bold, black letters. To the right of "TREX" is the text "Medical Corporation" in a smaller, regular font. Page 1 of 1 510(k) Number (if known): Device Name: LORAD MXU-125 or TMX-125 Mobile X-ray Unit Intended Use: The MXU-125 or TMX-125 is a Mobile ray unit intended for use in general radiographic medical procedures by a licensed professional. Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel h. Szyman (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic S10(k) Number Prescription Use 21 CFR 801.109 OR Over-the-Counter Use _ ORIGINAL