AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER is an FDA 510(k)-cleared medical device (K933916) manufactured by Ausonics Pty , 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 October 2, 1994. Regulation: 8.