510(k) K151383

NeuViz 128 Multi-slice CT Scanner System by Neusoft Medical Systems Co., Ltd. — Product Code JAK

K151383 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "NeuViz 128 Multi-slice CT Scanner System". The FDA issued a decision of Substantially Equivalent on November 4, 2015. 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.