PRACTIX CONVENIO

{0}------------------------------------------------ K042368 000 4 - 2004 ## 510(k) Summary In accordance with the requirements of 21 CFR 807.92 27 Auqust 2004 ### 1. Contact person Lynn Harmer Philips Medical Systems 22100 Bothell Everett Highway Bothell, Washington 98021-8431 Phone: (425) 487-7312 Fax: (425) 487-8666 #### 2. Device name and classification Trade name: Practix Convenio Classification name: Mobile x-ray system Classification panel: Radiology devices Requlatory status: Class II Device classification req. nr .: 21CFR 892.1720 #### 3. Predicate device Trade name: RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT (also known as PMX 2000) Manufacturer: Lorad 510(k) Number: K 894643 ### 4. Description The Practix Convenio is a motor driven battery supplied mobile x-ray unit to be operated indoors only. The system contains: Battery cluster including battery charger, two passive and two motor driven wheels, 20 kHz converter x-ray generator excluding the high voltage unit, 360° turn able column and a telescope arm to carry x-ray unit, x-ray tank (x-ray tube housing assembly and high voltage unit), collimator (beam limiting device) and a drawer to carry x-ray film cassettes and an anti scatter grid. The following components are optional: Removable pre filter, dose area product measurement, automatic exposure control and an infrared remote control. #### 5. Intended Use The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use. #### 6. Comparison to predicate device The Practix Convenio does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Practix Convenio to be substantially equivalent with the predicate device. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird. ## DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems North America 22100 Bothell Evert Highway BOTHELL WA 98021-8431 #### Re: K042368 OCT 4 - 2004 Trade/Device Name: Practix Convenio Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: 90 IZL Dated: August 27, 2004 Received: August 31, 2004 Dear Ms. Harmer: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. . . . . 1 {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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, Nancy C. brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K\$\phi\$42368 Device Name: Practix Convenio Indications For Use: The Practix Convenio is a mains independent motor driven mobile x-ray system, to x-ray body parts of patients to create images for medical diagnostic purposes. The Practix Convenio is intended to x-ray in rooms for medical use. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dorind A. Lymm (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number