The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s Vw.
| Device ID | K200418 |
| 510k Number | K200418 |
| Device Name: | VIVIX-S VW |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Anyang-si, KR 14055 |
| Contact | Jordin Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-20 |
| Decision Date | 2020-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394330340 | K200418 | 000 |
| 08809394330333 | K200418 | 000 |
| 08809394330326 | K200418 | 000 |
| 08809394330319 | K200418 | 000 |
| 08809394330302 | K200418 | 000 |
| 08809394330296 | K200418 | 000 |