The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s Wireless.
| Device ID | K122865 |
| 510k Number | K122865 |
| Device Name: | VIVIX-S WIRELESS |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | VIEWORKS CO., LTD. 951 STARBUCK ST UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung VIEWORKS CO., LTD. 951 STARBUCK ST UNIT J Fullerton, CA 92833 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-18 |
| Decision Date | 2013-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394330111 | K122865 | 000 |
| 08809394330104 | K122865 | 000 |