510(k) K052441

GE LOGIQ 7 ULTRASOUND BT05 by General Electric Co. — Product Code IYN

K052441 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE LOGIQ 7 ULTRASOUND BT05". The FDA issued a decision of Substantially Equivalent on September 21, 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.