K221008 is an FDA 510(k) clearance for the HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2). This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Shanghai Handy Medical Equipment Co., Ltd. (Baoshan District, CN). The FDA issued a Cleared decision on June 22, 2022, 78 days after receiving the submission on April 5, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K221008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2022 |
| Decision Date | June 22, 2022 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |