K090469 is an FDA 510(k) clearance for the CARESTREAM DRYVIEW 5850 LASER IMAGER. This device is classified as a Camera, Multi Format, Radiological (Class II - Special Controls, product code LMC).
Submitted by Carestream Health, Inc. (Oakdale, US). The FDA issued a Cleared decision on May 22, 2009, 88 days after receiving the submission on February 23, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2040.
| 510(k) Number | K090469 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2009 |
| Decision Date | May 22, 2009 |
| Days to Decision | 88 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 |