510(k) K061641

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO by Shimadzu Medical Systems — Product Code IYO

K061641 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO". The FDA issued a decision of Substantially Equivalent on July 14, 2006. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.