K213497 is an FDA 510(k) clearance for the ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW). 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 November 15, 2021, 14 days after receiving the submission on November 1, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K213497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 2021 |
| Decision Date | November 15, 2021 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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 |