SYSTEM, X-RAY, STATIONARY

{0}------------------------------------------------ K121854 Premarket Notification 510(k) Submission Section III 510(k) Summary Project #: M0042012Bc # AUG 222 2012 ### 510(k) Summary Section III This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: _ - Date of Submission: Mar 10. 2012 1. - 2. Sponsor Beijing Sinopharm Hundric Mediline Info. Tech. Co., Ltd The 3rd floor No.10, 5th Bo'xing Road, Beijing Economic-technological Development Zone, Beijing, 100176, P.R. China Contact Person: Tong han Position: Quality Manager Tel: +86-10-62968301 Fax: +86-10-62968315 Email: tong.han@tcl.com #### Submission Correspondent 3. Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai. 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net Proposed Device Identification 4. . .. . Proposed Device Name: Digital X-ray Radiography System Proposed Device Model: Eagle-DR2000A Classification: II Product Code: KPR Regulation Number: 21 CFR 892.1680 Review Panel: Radiology :: {1}------------------------------------------------ Intended Use Statement: The Digital X-ray Radiography System is indicated for use in generating radiographic imars of ' ' ' a anatomy. It is intended to replace radiographic film/screen systems in all general purpose dha, he us procedures. This device is not intended for mammographic applications. - Predicate Device Identification 5. 510(k) Number: K012389 Product Name: Revolution XR/d Digital Radiographic Imaging System Manufacturer: GE Medical System - Device Description 6. The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. The Digital X-ray Radiography System is designed to perform rudiographic X-ray cvario 1. consists of a control cabinet, a high voltage (HV) generator, an X-ray source assembly including an X-ray tube and an collimator, an Overhead Tube Suspension, a amorphous silicon (a-Si) detector, an elevating radiographic Table, a radiographic wall stand unit and a workstation. ### 7. Non-Clinical Test Conclusion Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: IEC60601-1+A1+A2:1988 Medical Electrical Equipment- Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment2, 1995 IEC 60601-1-2:2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests CFR 1020.30 Performance Standards for Ionizing Radiation Emitting Products CFR 1020.31 Radiographic equipment IEC 60601-2-7 (1998) Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators {2}------------------------------------------------ IEC 60601-1-3: 1994, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment IEC 60601-2-28: 1993, Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis IEC 60601-1-1:2000, Medical electrical equipment -- Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems. IEC60601-2-32:1994, Medical electrical equipment - Part 2: Particular requirements for the salety of associated equipment of X-ray equipment - Ed. 1.0. ISO 10993-5:2009 Standard, "Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity" ISO 10993-10:2010 Standard: Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization Substantially Equivalent Conclusion 8. > The proposed device, Digital X-ray Radiography System, is determined to be Substantially Equivalent (SE) to the predicate device, Revolution XR/d Digital Radiographic X-ray System (K012389). in respect of safety and effectiveness. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract image of an eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Beijing Sinopharm Hundric Mediline Info. Tech. Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd. P.O. Box 237-023 SHANGHAI 200030 CHINA AUG 2222012 Re: K121854 Trade/Device Name: Digital X-ray Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 21, 2012 Received: June 25, 2012 Dear Ms. Hong: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreases you the enactment date of the Medical Device Amendments, or to conniner of the roughts 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 r va may, disrelore, mance 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 class II (Special Controls), it may be subject to such 11 your device is blassified (200 regulations affecting your device can be found in Title 21, additional controls. Dations increases and to 895. 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 I lease of advised alar I DA 3 issuance ex or a complies with other requirements of the Act that FDA has made a determination that your device complies with other requirement that I DA has made a acteriminations administered by other Federal agencies. You must of any I coural statuted and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of {4}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality systems ( ( = ) regarine ( = ) = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will anow you to begin marketing your active as ween of your device to a legally marketed notification. The FDA indulig of Subsidential value and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you desire specific advice for your device of our leasening egaluation and Safety at (301) 796-607), please commer the regulation entitled, "Misbranding by reference to premarket 5450. Also, please note regarding the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 ℃FFCT at 005), product goblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Tour may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Section II Indications for Use 510(k) Number: Device Name: Digital X-ray Radiography System Indications for Use: The Digital X-ray Radiography System is indicated for use in generating radiographic image of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications. �PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OVER-THE-COUNTER USF (21 C) R 801 Subpart (1) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Division of Radiological Devices 5121854