510(k) K201745

Deep Learning Image Reconstruction for Gemstone Spectral Imaging by Ge Medical Systems, LLC — Product Code JAK

K201745 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Deep Learning Image Reconstruction for Gemstone Spectral Imaging". The FDA issued a decision of Substantially Equivalent on Dec 10, 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, LLC has 328 other 510(k) clearances on record.