FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)

FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR) is an FDA 510(k)-cleared medical device (K896050) manufactured by Fujifilm Medical System 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 December 13, 1989. Regulation: 8.