Sonosite MT Ultrasound System

Sonosite MT Ultrasound System is an FDA 510(k)-cleared medical device (K253448) manufactured by FUJIFILM Sonosite, 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 November 2, 2025. Regulation: 8.