510(k) K173341

Vivid E80, Vivid E90, Vivid E95 by GE Medical Systems — Product Code IYN

K173341 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "Vivid E80, Vivid E90, Vivid E95". The FDA issued a decision of Substantially Equivalent on Nov 2, 2017. 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 has 328 other 510(k) clearances on record.