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 |