
Fujifilm Medical System U.S.A., Inc.
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FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER is an FDA 510(k)-cleared medical device (K033561) 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 November 25, 2003. Regulation: 8.