Terason uSmart 3200T Plus Ultrasound System

Terason uSmart 3200T Plus Ultrasound System is an FDA 510(k)-cleared medical device (K201633) manufactured by Teratech 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 July 1, 2020. Regulation: 8.