MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM

{0}------------------------------------------------ ## 510(k) Summary 510(k) Number K052541 AVANT Medical Systems 3501 Thomas Road, Unit 2 Santa Clara, CA 95054, USA (408)988-6600 Tel: (408)988-6618 Fax: October 20, 2005 Contact: Eddy Yee, VP International Marketing - Identification of the Device: 1. Proprietary-Trade Name: Model HF-50R Computer Controlled X-Ray System Classification Name: Stationary X-Ray System Product Code 90 KPR Common/Usual Name: Diagnostic X-Ray System. - 2. Equivalent legally marketed device: Siemens Multix Stationary X-Ray System (K001201) - 3. Indications for Use (intended use) Model HF-50R Computer Controlled X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. - 4. Description of the Device: HF50-R High Frequency Special Radiography System can be applied in hospitals of different levels to meet the requirements of radiographic diagnosis. The system is complete, consisting of a 50kw generator, X-Ray tube assembly, collimator, tube mounting hardware, and an x-ray table. This product is applicable to clinical diagnostic radiography in all hospitals large or small. It has functions such as ionization chamber automatic exposure control (AEC), automatic radiography (APR), general radiography etc. It is applicable to the radiography of various parts of human body. It is a dedicated radiographic device for gastro-intestinal tract and the like. The technical characteristics parallels to that in the world in the late '90s of last century. It can also be used in scientific research and education of medical scientific research institutes and medical colleges. Power supply requirements: three phase: 380V, 50/60Hz; single phase: 220V, 50/60 Hz; fluctuation range for voltage: 10%; capacity: 55kVA. Environment requirements: temperature: 15-35C; relative humidity: 45-75%. Atmospheric pressure: 80.0kPa-106.0kPa. - 5. Safety and Effectiveness, comparison to predicate device. The results of bench, test laboratory and clinical testing indicates that the new device is as safe and effective as the predicate devices. {1}------------------------------------------------ ## 6. Substantial Equivalence Chart, | Characteristic | Siemens Multix<br>Stationary X-Ray<br>System (K001201) | Model HF-50R<br>Computer<br>Controlled X-Ray<br>System | |----------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------| | Intended Use: | General purpose<br>diagnostic X-ray unit | SAME | | Energy Source: | Various line power<br>sources | SAME | | User Interface | Depends on Control<br>Console option<br>chosen. Mainly<br>dedicated touch<br>controls | LCD Screen with<br>pushbuttons | | Maximum output | Depends on model of<br>generator chosen.<br>Models available from<br>32 kW to 80 kW | 50 kW | | Tube mount | Ceiling or column<br>mount | SAME | | Receptor mount | In table or wall<br>mounted bucky | SAME | | Collimator | Manual | SAME | | Method of Control | Dedicated push button<br>Controls | SAME | | Performance Standard | 21 CFR 1020.30 | SAME | | Electrical safety: | UL 2601,<br>IEC 60601-1<br>EMC 60601-1-2 | SAME | ## 7. Conclusion After analyzing both bench and user testing data as well as external laboratory testing to applicable standards, it is the conclusion of Avant Medical Systems that the Model HF-50R Computer Controlled X-Ray System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Avant Medical Systems % Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015 Re: K052541 NOV - 3 2005 Trade/Device Name: Model HF-50R Computer Controlled X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: September 14, 2005 Received: September 21, 2005 Dear Mr. Kamm: 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. {3}------------------------------------------------ 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/industry/support/index.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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known):K052541 Device Name: Model HF-50R Computer Controlled X-Ray System Indications For Use: Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.. Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C. Brogdon (Division Sign-Off)/ Division of Reprodictive Abdominal, and Radiological Devices 510(k) Number K052541 Page 1 of 1