510(k) K053435

GE VOLUSON I by General Electric Co. — Product Code IYN

K053435 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE VOLUSON I". The FDA issued a decision of Substantially Equivalent on December 16, 2005. 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.