K111566 is an FDA 510(k) clearance for the DRYVIEW CHROMA IMAGING SYSTEM. This device is classified as a Camera, Multi Format, Radiological (Class II - Special Controls, product code LMC).
Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on October 6, 2011, 122 days after receiving the submission on June 6, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2040.
| 510(k) Number | K111566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2011 |
| Decision Date | October 06, 2011 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LMC — Camera, Multi Format, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2040 |