The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Hyperion X9 Pro, Newtom Giano Hr, X-radius Trio Plus.
| Device ID | K214084 |
| 510k Number | K214084 |
| Device Name: | Hyperion X9 Pro, NewTom GiANO HR, X-RADiUS TRiO PLUS |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | CEFLA S.C. Via Selice Provinciale 23/A Imola, IT 40026 |
| Contact | Lorenzo Bortolotti |
| Correspondent | Lorenzo Bortolotti CEFLA S.C. Via Selice Provinciale 23/A Imola, IT 40026 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-01-20 |