510(k) K231965

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 by GE Medical Systems Ultrasound and Primary Care Diagnostics — Product Code IYN

K231965 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics for the device "Voluson Expert 22, Voluson Expert 20, Voluson Expert 18". The FDA issued a decision of Substantially Equivalent on October 30, 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 Diagnostics has at least 10 other 510(k) clearances on record.