SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM

SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K012080) 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 August 28, 2001. Regulation: 8.