510(k) K233692

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

K233692 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics for the device "Voluson Signature 20, Voluson Signature 18". The FDA issued a decision of Substantially Equivalent on March 7, 2024. 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.