510(k) K242223

SuperSonic HepaVu by Supersonic Imagine — Product Code IYN

K242223 is an FDA 510(k) premarket notification submitted by Supersonic Imagine for the device "SuperSonic HepaVu". The FDA issued a decision of Substantially Equivalent on September 20, 2024. 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.