Submission Details
| 510(k) Number | K060079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2006 |
| Decision Date | February 08, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K060079 is an FDA 510(k) clearance for the KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on February 8, 2006, 29 days after receiving the submission on January 10, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K060079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 10, 2006 |
| Decision Date | February 08, 2006 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUH — System, X-ray, Extraoral Source, Digital |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.1800 |