Synapse PACS (7.5)

Synapse PACS (7.5) is an FDA 510(k)-cleared medical device (K243647) 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 June 29, 2025. Regulation: 8.