510(k) K251022

3D-SHAPER by 3D-Shaper Medical S.L — Product Code KGI

K251022 is an FDA 510(k) premarket notification submitted by 3D-Shaper Medical S.L for the device "3D-SHAPER". The FDA issued a decision of Substantially Equivalent on September 5, 2025. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. 3D-Shaper Medical S.L has at least 1 other 510(k) clearance on record.