The following data is part of a premarket notification filed by Cefla Sc with the FDA for Hyperion X5.
| Device ID | K161900 |
| 510k Number | K161900 |
| Device Name: | HYPERION X5 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | CEFLA SC VIA SELICE PROVINCIALE 13/A Imola, IT 40026 |
| Contact | Silvia Sansavini |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA A. BONETTI 3/A Imola, IT 40026 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2016-12-09 |
| Summary: | summary |