510(k) K213999

Deep Learning Image Reconstruction by Ge Medical Systems, LLC — Product Code JAK

K213999 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Deep Learning Image Reconstruction". The FDA issued a decision of Substantially Equivalent on February 18, 2022. 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, LLC has at least 10 other 510(k) clearances on record.