DRX-Evolution/Plus with Dual Energy

DRX-Evolution/Plus with Dual Energy is an FDA 510(k)-cleared medical device (K190330) 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 3, 2019. Regulation: 8.