510(k) K050510

ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 by Shimadzu Medical Systems — Product Code IYN

K050510 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.