510(k) K131514

GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM by Ge Vingmed Ultrasound AS — Product Code IYN

K131514 is an FDA 510(k) premarket notification submitted by Ge Vingmed Ultrasound AS for the device "GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 2013. 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.