510(k) K060542

GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX by General Electric Co. — Product Code IYN

K060542 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX". The FDA issued a decision of Substantially Equivalent on March 31, 2006. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. General Electric Co. has at least 10 other 510(k) clearances on record.