510(k) K181685

Vivid E80, Vivid E90, Vivid E95 by GE Medical Systems Ultrasound And Primary Care Diagnostics — Product Code IYN

K181685 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound And Primary Care Diagnostics for the device "Vivid E80, Vivid E90, Vivid E95". The FDA issued a decision of Substantially Equivalent on Oct 25, 2018. 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 82 other 510(k) clearances on record.