510(k) K933916

AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER by Ausonics Pty , Ltd. — Product Code IYN

K933916 is an FDA 510(k) premarket notification submitted by Ausonics Pty , Ltd. for the device "AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER". The FDA issued a decision of Substantially Equivalent on October 3, 1994. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ausonics Pty , Ltd. has at least 10 other 510(k) clearances on record.