UNEXEF-38G ULTRASOUND SYSTEM

UNEXEF-38G ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K131973) manufactured by Toyota Tsusho 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 November 17, 2014. Regulation: 8.