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 |