The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Hyperion X5, Newtom Go, X-radius Compact.
| Device ID | K200688 |
| 510k Number | K200688 |
| Device Name: | Hyperion X5, NewTom GO, X-RADiUS COMPACT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-16 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837932925 | K200688 | 000 |
| 08033837932949 | K200688 | 000 |
| 08033837932932 | K200688 | 000 |
| 08033837932901 | K200688 | 000 |
| 08033837932895 | K200688 | 000 |
| 08033837932888 | K200688 | 000 |