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Fujifilm Medical System U.S.A., Inc.
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SYNAPSE 3D BASIC TOOLS is an FDA 510(k)-cleared medical device (K101662) 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 July 25, 2010. Regulation: 8.