FDR AQRO (DR-XD 1000)

FDR AQRO (DR-XD 1000) is an FDA 510(k)-cleared medical device (K170858) 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 23, 2017. Regulation: 8.