510(k) K043452

TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM by Sonosite,Inc. — Product Code IYN

K043452 is an FDA 510(k) premarket notification submitted by Sonosite,Inc. for the device "TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Sonosite,Inc. has at least 10 other 510(k) clearances on record.