510(k) K915715

CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER by Ausonics Pty , Ltd. — Product Code IYO

K915715 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER". The FDA issued a decision of Substantially Equivalent on July 2, 1992. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.