K221512 is an FDA 510(k) clearance for the Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW). This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on July 20, 2022, 57 days after receiving the submission on May 24, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K221512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2022 |
| Decision Date | July 20, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MQB - Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |