TERASON USMART3200T ULTRASOUND SYSTEM

TERASON USMART3200T ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K131209) 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 May 23, 2013. Regulation: 8.