510(k) K123097

DOSE TRACKING SYSTEM MODEL XIDF-DTS801 by Toshiba America Medical Systems, In.C — Product Code JAA

K123097 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "DOSE TRACKING SYSTEM MODEL XIDF-DTS801". The FDA issued a decision of Substantially Equivalent on February 13, 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.