510(k) K003515

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

K003515 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200". The FDA issued a decision of Substantially Equivalent on February 12, 2001. 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.