The following data is part of a premarket notification filed by Trophy with the FDA for Cs Imaging.
Device ID | K173622 |
510k Number | K173622 |
Device Name: | CS 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 | 2017-11-24 |
Decision Date | 2018-01-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
60192155500671 | K173622 | 000 |
60192155500688 | K173622 | 000 |