The following data is part of a premarket notification filed by Vieworks Co., Ltd. with the FDA for Vivix-s Fw (model: Fxrd-2530faw, Fxrd-3643faw, Fxrd-4343faw).
| Device ID | K221512 |
| 510k Number | K221512 |
| Device Name: | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Dongan-gu Anyang-si, KR 14055 |
| Contact | Kevin Oh |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, CA 92612 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-24 |
| Decision Date | 2022-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809394330609 | K221512 | 000 |
| 08809394330593 | K221512 | 000 |
| 08809394330586 | K221512 | 000 |