510(k) K132106

INFINIX ANGIO WORKSTATION W/DTS SOFTWARE by Toshiba America Medical Systems, In.C — Product Code JAA

K132106 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "INFINIX ANGIO WORKSTATION W/DTS SOFTWARE". The FDA issued a decision of Substantially Equivalent on November 12, 2013. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Toshiba America Medical Systems, In.C has at least 10 other 510(k) clearances on record.