FCT iSTREAM Phase 1

FCT iSTREAM Phase 1 is an FDA 510(k)-cleared medical device (K233583) 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 April 25, 2024. Regulation: 8.