The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Intraoral Dental X-ray System 70-x.
| Device ID | K851095 |
| 510k Number | K851095 |
| Device Name: | INTRAORAL DENTAL X-RAY SYSTEM 70-X |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Contact | Jy Sevestre |
| Correspondent | Jy Sevestre TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-09-03 |