K152162 is an FDA 510(k) clearance for the Myray- HYPERION X5. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on December 24, 2015, 143 days after receiving the submission on August 3, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K152162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2015 |
| Decision Date | December 24, 2015 |
| Days to Decision | 143 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 |