ALOKA SD-3500 ULTRASOUND SYSTEM

ALOKA SD-3500 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K060059) 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 January 12, 2006. Regulation: 8.