The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Myray- Hyperion X5.
| Device ID | K152162 |
| 510k Number | K152162 |
| Device Name: | Myray- HYPERION X5 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | CEFLA S.C. VIA SELICE PROVINCIALE 23/A Imola, IT 40026 |
| Contact | Silvia Sansavini |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A. BONETTI 3/A Imola, IT 40026 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-12-24 |
| Summary: | summary |