510(k) K211524

LOGIQ E10s, LOGIQ Fortis by GE Healthcare — Product Code IYN

K211524 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "LOGIQ E10s, LOGIQ Fortis". The FDA issued a decision of Substantially Equivalent on August 27, 2021. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. GE Healthcare has at least 10 other 510(k) clearances on record.