CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR

CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR is an FDA 510(k)-cleared medical device (K130464) 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 June 6, 2013. Regulation: 8.