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 | K190496 |
| 510k Number | K190496 |
| 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 | Elena Arcangeli |
| Correspondent | Elena Arcangeli CEFLA S.C. Via Selice Provinciale 23/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 | 2019-02-28 |
| Decision Date | 2019-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837931904 | K190496 | 000 |
| 08033837931898 | K190496 | 000 |
| 08033837931881 | K190496 | 000 |