510(k) K071291

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

K071291 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 January 9, 2008. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.