K221587 is an FDA 510(k) clearance for the DHX-70H, XTG-70H. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Digimed Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on March 3, 2023, 275 days after receiving the submission on June 1, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K221587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2022 |
| Decision Date | March 03, 2023 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |