The following data is part of a premarket notification filed by Trophy with the FDA for Kodak Rvg 6500 System And Kodak Rvg 6500 Ips System.
| Device ID | K093478 |
| 510k Number | K093478 |
| Device Name: | KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM |
| Classification | System, X-ray, Extraoral Source, Digital |
| 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 | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2010-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60192155008061 | K093478 | 000 |
| 60192155008054 | K093478 | 000 |
| 60192155008047 | K093478 | 000 |