Terason uSmart3300 Ultrasound System

Terason uSmart3300 Ultrasound System is an FDA 510(k)-cleared medical device (K150148) manufactured by Teratech Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2015. Regulation: 8.