510(k) K150087

Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System by Ge Vingmed Ultrasound AS — Product Code IYN

K150087 is an FDA 510(k) premarket notification submitted by Ge Vingmed Ultrasound AS for the device "Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System". The FDA issued a decision of Substantially Equivalent on March 4, 2015. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Ge Vingmed Ultrasound AS has at least 10 other 510(k) clearances on record.