510(k) K261668

Venue Go by GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC — Product Code IYN

K261668 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC for the device "Venue Go". The FDA issued a decision of Substantially Equivalent on Aug 7, 2026. 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, LLC has 84 other 510(k) clearances on record.