K111649 is an FDA 510(k) clearance for the CS 7600. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).
Submitted by Carestream Health, Inc. (Atlanta, US). The FDA issued a Cleared decision on September 23, 2011, 102 days after receiving the submission on June 13, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K111649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2011 |
| Decision Date | September 23, 2011 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| 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 |