AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION

AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION is an FDA 510(k)-cleared medical device (K920307) 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 May 18, 1992. Regulation: 8.