
Fujifilm Medical System U.S.A., Inc.
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FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB is an FDA 510(k)-cleared medical device (K110202) 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 February 7, 2011. Regulation: 8.