DRX-Evolution with Carestream Digital Tomosynthesis

DRX-Evolution with Carestream Digital Tomosynthesis is an FDA 510(k)-cleared medical device (K191879) 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 December 19, 2019. Regulation: 8.