Synapse 3D Perfusion Analysis

Synapse 3D Perfusion Analysis is an FDA 510(k)-cleared medical device (K162287) manufactured by Fujifilm Medical Systems 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 April 5, 2017. Regulation: 8.