510(k) K161157

Vitrea CT Dual Energy Image View by Vital Images, Inc. — Product Code JAK

K161157 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "Vitrea CT Dual Energy Image View". The FDA issued a decision of Substantially Equivalent on November 3, 2016. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Vital Images, Inc. has at least 10 other 510(k) clearances on record.