ECHELON Synergy V10.0

ECHELON Synergy V10.0 is an FDA 510(k)-cleared medical device (K233687) manufactured by FUJIFILM Healthcare Americas Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 2024. Regulation: 8.