510(k) K253185

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System by Carestream Health — Product Code IZL

K253185 is an FDA 510(k) premarket notification submitted by Carestream Health for the device "Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System". The FDA issued a decision of Substantially Equivalent on March 11, 2026. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Carestream Health has at least 10 other 510(k) clearances on record.