FDR D-EVO flat Panel Detector System

FDR D-EVO flat Panel Detector System is an FDA 510(k)-cleared medical device (K153464) manufactured by Fujifilm Medical Systems U.S.A, 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 April 7, 2016. Regulation: 8.