510(k) K151919

Vitrea CT Lung Density Analysis Software by Vital Images, Inc. — Product Code JAK

K151919 is an FDA 510(k) premarket notification submitted by Vital Images, Inc. for the device "Vitrea CT Lung Density Analysis Software". The FDA issued a decision of Substantially Equivalent on October 10, 2015. 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.