The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Orthoslice Os1000 Series; Panoramic Orthoslice Os 1000: Os1000, Os1000e Panoramic And Cephalometric Orthoslice Os1000c,.
| Device ID | K991455 |
| 510k Number | K991455 |
| Device Name: | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-06-25 |