510(k) K180572

AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 by Supersonic Imagine — Product Code IYN

K180572 is an FDA 510(k) premarket notification submitted by Supersonic Imagine for the device "AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10". The FDA issued a decision of Substantially Equivalent on May 29, 2018. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Supersonic Imagine has at least 10 other 510(k) clearances on record.