K253185 is an FDA 510(k) clearance for the Lux HD Detectors, DRX-LC Detector, 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 (Rochester, US). The FDA issued a Cleared decision on March 11, 2026, 166 days after receiving the submission on September 26, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.
| 510(k) Number | K253185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2025 |
| Decision Date | March 11, 2026 |
| Days to Decision | 166 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 |