The following data is part of a premarket notification filed by Trophy with the FDA for Cs 3d Imaging.
| Device ID | K151837 |
| 510k Number | K151837 |
| Device Name: | CS 3D Imaging |
| Classification | System, Image Processing, Radiological |
| Applicant | TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg, FR 77435 |
| Contact | Marie-pierre Labat-camy |
| Correspondent | Marie-pierre Labat-camy TROPHY 4 RUE F. PELLOUTIER Croissy-beaubourg, 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 | 2015-07-06 |
| Decision Date | 2015-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155319587 | K151837 | 000 |
| 60192155943010 | K151837 | 000 |
| 60192155319556 | K151837 | 000 |