The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Digital Radiography System, Model Qxr-16.
| Device ID | K080553 |
| 510k Number | K080553 |
| Device Name: | DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 |
| Classification | System, X-ray, Stationary |
| Applicant | VIEWORKS CO., LTD. 340 SHADY GROVE ROAD Flintville, TN 37335 |
| Contact | Charlie Mack |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2008-04-16 |
| Summary: | summary |