The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Digital Radiography System, Model: Qxr-9.
| Device ID | K073056 |
| 510k Number | K073056 |
| Device Name: | DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIEWORKS CO., LTD. 307-2, SANGDAEWON-DONG JUNGWON-GU, SEONGNAM-CITY, Gyeonggi-do, KR 462-806 |
| Contact | Kim Raza |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-30 |
| Decision Date | 2007-11-13 |
| Summary: | summary |