MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM

MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K100186) manufactured by Medison 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 23, 2010. Regulation: 8.