510(k) K212067

Deep Learning Image Reconstruction by Ge Healthcare Japan Corporation — Product Code JAK

K212067 is an FDA 510(k) premarket notification submitted by Ge Healthcare Japan Corporation for the device "Deep Learning Image Reconstruction". The FDA issued a decision of Substantially Equivalent on September 17, 2021. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Ge Healthcare Japan Corporation has at least 9 other 510(k) clearances on record.