510(k) K193289

FastStroke, CT Perfusion 4D by GE Medical Systems SCS — Product Code JAK

K193289 is an FDA 510(k) premarket notification submitted by GE Medical Systems SCS for the device "FastStroke, CT Perfusion 4D". The FDA issued a decision of Substantially Equivalent on November 12, 2020. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. GE Medical Systems SCS has at least 10 other 510(k) clearances on record.