K120062 is an FDA 510(k) clearance for the DRX-REVOLUTION MOBILE X-RAY SYSTEM. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).
Submitted by Carestream Health, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 13, 2012, 95 days after receiving the submission on January 9, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K120062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2012 |
| Decision Date | April 13, 2012 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZL — System, X-ray, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1720 |