AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER is an FDA 510(k)-cleared medical device (K945957) manufactured by Kleinfeld, Kaplan and Becker. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1996. Regulation: 8.