Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System— 510(k) K253185
Substantially EquivalentCarestream Health
FDA 510(k) clearance K253185 for Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System, Substantially Equivalent on 2026-03-11. Applicant: Carestream Health. Device class: 2.
Summary
Carestream Health's record names three items: Lux HD Detectors, the DRX-LC Detector and the DRX-Revolution Mobile X-Ray System. They're filed under IZL, mobile x-ray systems.
Class II, 21 CFR 892.1720. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Carestream Health filed from Rochester, New York. The decision came 166 calendar days after receipt (September 26, 2025 to March 11, 2026).
Clearance details
- Applicant
- Carestream Health
- Product code
- Product code IZL
- Device class
- Class 2
- Regulation
- 21 CFR 892.1720
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code IZL
view allMore clearances from Carestream Health
view allAdverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.