The following data is part of a premarket notification filed by Trophy with the FDA for Cs 9600.
| Device ID | K181136 |
| 510k Number | K181136 |
| Device Name: | CS 9600 |
| Classification | X-ray, Tomography, Computed, Dental |
| 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 | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155501197 | K181136 | 000 |
| 60192155501548 | K181136 | 000 |
| 60192155942396 | K181136 | 000 |