Carestream DRX-1 System with DRX Plus 4343 Detectors

Carestream DRX-1 System with DRX Plus 4343 Detectors is an FDA 510(k)-cleared medical device (K153142) 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 November 24, 2015. Regulation: 8.