K093478 is an FDA 510(k) clearance for the KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Trophy (Croissy-Beaubourg, FR). The FDA issued a Cleared decision on April 26, 2010, 168 days after receiving the submission on November 9, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K093478 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2009 |
| Decision Date | April 26, 2010 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | MUH - System, X-ray, Extraoral Source, Digital |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |