510(k) K061682

GE VOLUSON E8 ULTRASOUND SYSTEM by General Electric Co. — Product Code IYO

K061682 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VOLUSON E8 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. General Electric Co. has at least 10 other 510(k) clearances on record.