510(k) K253686

True Definition DL by Ge Healthcare Japan Corporation — Product Code JAK

K253686 is an FDA 510(k) premarket notification submitted by Ge Healthcare Japan Corporation for the device "True Definition DL". The FDA issued a decision of Substantially Equivalent on March 23, 2026. 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.