510(k) K121792

NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM by Neusoft Medical Systems Co., Ltd. — Product Code JAK

K121792 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM". The FDA issued a decision of Substantially Equivalent on November 16, 2012. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neusoft Medical Systems Co., Ltd. has at least 10 other 510(k) clearances on record.