510(k) K222191

Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 by Supersonic Imagine — Product Code IYN

K222191 is an FDA 510(k) premarket notification submitted by Supersonic Imagine for the device "Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40". The FDA issued a decision of Substantially Equivalent on October 28, 2022. 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.