Carestream DRX-1 System with DRX Plus 2530 Detectors

Carestream DRX-1 System with DRX Plus 2530 Detectors is an FDA 510(k)-cleared medical device (K183245) manufactured by Carestream Health, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 2019. Regulation: 8.