The following data is part of a premarket notification filed by Trophy with the FDA for Kodak 9500.
| Device ID | K082972 |
| 510k Number | K082972 |
| Device Name: | KODAK 9500 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG Marne La Vallee Cedex 2, FR 77437 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 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 | 2008-10-06 |
| Decision Date | 2008-12-05 |