Cleared Traditional

3D-SHAPER

K251022 · 3D-Shaper Medical S.L · Radiology
Sep 2025
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K251022 is an FDA 510(k) clearance for the 3D-SHAPER, a Densitometer, Bone (Class II — Special Controls, product code KGI), submitted by 3D-Shaper Medical S.L (Barcelona, ES). The FDA issued a Cleared decision on September 5, 2025, 156 days after receiving the submission on April 2, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1170.

Submission Details

510(k) Number K251022 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2025
Decision Date September 05, 2025
Days to Decision 156 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KGI — Densitometer, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1170