510(k) K261132

Healium Intelliscan LX192LC by Healium Intelliscan Corporation — Product Code IYN

K261132 is an FDA 510(k) premarket notification submitted by Healium Intelliscan Corporation for the device "Healium Intelliscan LX192LC". The FDA issued a decision of Substantially Equivalent on May 5, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550.