
Fujifilm Medical System U.S.A., Inc.
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FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR is an FDA 510(k)-cleared medical device (K093427) 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 January 20, 2010. Regulation: 8.