OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS is an FDA 510(k)-cleared medical device (K102989) manufactured by Chang Gung Medical Technology Co., Ltd. Linkou Fac. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 8, 2010. Regulation: 8.