510(k) K061643

ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO by Shimadzu Medical Systems — Product Code IYN

K061643 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO". The FDA issued a decision of Substantially Equivalent on July 27, 2006. 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.