The following data is part of a premarket notification filed by Trophy with the FDA for Dental Imaging Software.
| Device ID | K141607 |
| 510k Number | K141607 |
| Device Name: | DENTAL IMAGING SOFTWARE |
| Classification | System, Image Processing, Radiological |
| Applicant | TROPHY 4 RUE F. PELLOUTIER CROISSY - BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 4 RUE F. PELLOUTIER CROISSY - BEAUBOURG Marne La Vallee Cedex 2, FR 77435 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155319570 | K141607 | 000 |
| 60192155314308 | K141607 | 000 |