The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Hyperion X9.
| Device ID | K123381 |
| 510k Number | K123381 |
| Device Name: | HYPERION X9 |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Berthoin Claude |
| Correspondent | Berthoin Claude CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2013-05-10 |