FDX Console (DR-ID300CL) Software

FDX Console (DR-ID300CL) Software is an FDA 510(k)-cleared medical device (K170451) 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 March 15, 2017. Regulation: 8.