ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM

ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K043196) 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 November 29, 2004. Regulation: 8.