510(k) K100067

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM by Toshiba America Medical Systems, In.C — Product Code ITX

K100067 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 2010. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.