510(k) K112054

INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V by Toshiba Medical Systems Corporation, Japan — Product Code JAA

K112054 is an FDA 510(k) premarket notification submitted by Toshiba Medical Systems Corporation, Japan for the device "INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V". The FDA issued a decision of Substantially Equivalent on Aug 5, 2011. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Toshiba Medical Systems Corporation, Japan has 8 other 510(k) clearances on record.