510(k) K082224

DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC by Shimadzu Medical Systems — Product Code ITX

K082224 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC". The FDA issued a decision of Substantially Equivalent on December 15, 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.