510(k) K261313

Vivid Explorer/Vivid Advanced/Vivid Focus by GE Medical Systems Ultrasound and Primary Care Diagnostics — Product Code IYN

K261313 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound and Primary Care Diagnostics for the device "Vivid Explorer/Vivid Advanced/Vivid Focus". The FDA issued a decision of Substantially Equivalent on September 2, 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 has at least 10 other 510(k) clearances on record.