K221955 is an FDA 510(k) clearance for the Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Realcloud Imaging Inc. Dba Realcloud Imaging (Ames, US). The FDA issued a Cleared decision on August 31, 2022, 57 days after receiving the submission on July 5, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K221955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | August 31, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |