Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System is an FDA 510(k)-cleared medical device (K253185) manufactured by Carestream Health. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2026. Regulation: 8.