CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER is an FDA 510(k)-cleared medical device (K915715) 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 July 1, 1992. Regulation: 8.