510(k) K232186

LOGIQ e by Ge Medical Systems Ultrasound and Primary Care Diagnostic, — Product Code IYN

K232186 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Ultrasound and Primary Care Diagnostic, for the device "LOGIQ e". The FDA issued a decision of Substantially Equivalent on November 3, 2023. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Medical Systems Ultrasound and Primary Care Diagnostic, has at least 2 other 510(k) clearances on record.