ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER

ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER is an FDA 510(k)-cleared medical device (K974544) manufactured by Aloka Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 1998. Regulation: 8.