K223930 is an FDA 510(k) clearance for the A1417MCW/A1717MCW/F1417MCW. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).
Submitted by H&abyz Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on March 6, 2023, 66 days after receiving the submission on December 30, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K223930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2022 |
| Decision Date | March 06, 2023 |
| Days to Decision | 66 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 |