K213568 is an FDA 510(k) clearance for the DRX-Rise 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 (Rochester, US). The FDA issued a Cleared decision on March 23, 2022, 134 days after receiving the submission on November 9, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K213568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2021 |
| Decision Date | March 23, 2022 |
| Days to Decision | 134 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 |