DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA

{0}------------------------------------------------ 510(k) Submission - 1210SGA ## Special 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: _ December 5th, 2011 - 1. Company sponsoring this submission: Name -Rayence Co., Ltd. Address - 2F/4F, 23-8, Hwasung-si, Seogu-dong, Gyeonggi-do, 445-170, Korea Telephone - +82-31-8015-6459 Fax - +82-31-8015-6598 Contact - Kee Dock Kim / Manager Internet - http://www.rayence.com - 2. Official correspondent (U.S. Designated agent) Mtech Group 12946 Kimberley Ln Houston, TX 77079 Tel: +713-467-2607 Fax: +713-464-8880 Contact person: Mr. Dave Kim Email: davekim@mtech-inc.net - 3. Device : | Trade/proprietary name | : 1210SGA | |------------------------|-------------------------------------| | Common Name | : Digital Flat Panel X-ray Detector | | Classification Name | : Solid State X-ray Imaging Device | - 4. Predicate Device : | Manufacturer | : Rayence Co., Ltd. | |---------------|---------------------------------------------| | Device | : Xmaru1210P | | 510(k) Number | : K101590 (Decision Date - Nov. 29th, 2010) | Rayence Co., Ltd. {1}------------------------------------------------ #### 5. Classifications Names & Citations : 21CFR 892.1650, MQB, Solid State X-ray Imaging Device, Class2 #### 6. Description : - 6.1 General 1210SGA is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this SIOK submission) for a radiographic diagnosis and analysis. - 7. Indication for use : 1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck, spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography. - 8. Comparison with predicate device : Rayence Co., Ltd. believes that 1210SGA is substantially equivalent in comparison with Xmaru 1210P of Rayence Co., Ltd. - 9. Safety, EMC and Performance Data : Electrical, mechanical, environmental safety and performance testing according to standard ENVIEC 60601-1 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory. - 9. Conclusions : In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Rayence Co., Ltd. concludes that 1210SCA is safe and effective and substantially equivalent in comparison with the predicate device as described Rayence Co., Ltd. {2}------------------------------------------------ 510(k) Submission - 1210SGA herein. - 10. Rayence Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by FDA. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font. # 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 Rayence Co., Ltd. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 12946 Kimberly Lane HOUSTON TX 77079 AUG 23 2013 Re: K113630 Trade/Device Name: Digital Flat Panel X-Ray Detector/1210SGA Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: December 5, 2011 Received: December 8, 2011 Dear Mr. Kim: This letter corrects our substantially equivalent letter of December 29, 2011. 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 r ou may, decree, mains 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 additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 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 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 or my 1 vith all the Act's requirements, 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 (en section 510(c) premarket will allow you to begin marketing your active of your device to a legally marketed notification. The FDA indulig of substandar equivalier of 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 Parts 801 and If you desire specific advice for your device of our insolution and Safety at (301) 796809), please contact the Office of In Vitro Diaguostic Device Lyssence on premarket 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5450. Also, please note the regulation variations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (27 Crc C at 605), picts of the CDRH's Office http://www.fda.gov/MedicalDevices/Safety/Reports/coolem/default.html of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational 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}------------------------------------------------ ### Indications for Use 510(K) Number (if known): K ! | 3630 Device Name: Digital Flat Panel X-Ray Delector / 1210SGA Indications for Use: 1210SGA Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for human anatomy including head, neck. spinal column, arm. leg and peripheral (foot, hand, wrist, fingers, etc.). It is intended to replace film based radiographic diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health professionals. Not to be used for mammography. AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation(ODE) Mary S Pool (Division Sign-Off) Division of Radiological Devices Evaluation and Safet Office of In Vitro Diagnostic Device Evaluation and Safety 510K. K113630 Page 1 of 1