510(k) K101149

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

K101149 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 October 13, 2010. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Ge Vingmed Ultrasound AS has at least 10 other 510(k) clearances on record.