The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Digipan / Dpi.
| Device ID | K012514 |
| 510k Number | K012514 |
| Device Name: | DIGIPAN / DPI |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-12-21 |