510(k) K101868

INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V by Toshiba America Medical Systems, In.C — Product Code OWB

K101868 is an FDA 510(k) premarket notification submitted by Toshiba America Medical Systems, In.C for the device "INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V". The FDA issued a decision of Substantially Equivalent on September 7, 2010. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), 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.