510(k) K061525

GE VIVID - I by General Electric Co. — Product Code IYN

K061525 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VIVID - I". The FDA issued a decision of Substantially Equivalent on July 3, 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.