510(k) K191007

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

K191007 is an FDA 510(k) premarket notification submitted by Supersonic Imagine for the device "Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems". The FDA issued a decision of Substantially Equivalent on October 25, 2019. 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.