The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Modification To Digipan.
| Device ID | K991912 |
| 510k Number | K991912 |
| Device Name: | MODIFICATION TO DIGIPAN |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TROPHY RADIOLOGIE 4 RUE F. PELLOUTIER CROISSY-BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marir-pierre Labat-camy |
| Correspondent | Marir-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 | 1999-06-07 |
| Decision Date | 1999-06-22 |