ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM

ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K954022) 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 16, 1996. Regulation: 8.