3D-SHAPER

FDA 510(k) K251022 · 3D-Shaper Medical S.L

Substantially Equivalent

510(k) numberK251022

Submission

Device name
3D-SHAPER
Applicant
3D-Shaper Medical S.L
Barcelona, ES
Received
April 2, 2025
Decision date
September 5, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGI – Densitometer, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1170
Specialty
Radiology

Other 510(k)s with product code KGI

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K254072BoneVueKGI · Traditional Curvebeam AI / Curvebeam, LLC09/11/2026SE
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K242295BunkerHill BMDKGI · Traditional BunkerHill Health04/08/2025SE
K243218TBS iNsight (V4)KGI · Traditional Medimaps Group SA01/17/2025SE
K220402VirtuOstKGI · Traditional O.N. Diagnostics05/19/2023SE
K2208223D-SHAPERKGI · Traditional 3D-Shaper Medical S.L12/09/2022SE
K213760ABMD SoftwareKGI · Traditional HeartLung Corporation07/29/2022SE
K191112GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional GE Medical Systems Ultrasound & Primary Care…09/19/2019SE
K180782AriaKGI · Traditional GE Medical Systems Ultrasound & Primary Care…04/20/2018SE
K161682GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional GE Medical Systems Ultrasound & Primary Care…12/02/2016SE

More from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

510(k)DeviceDecision
K2208223D-SHAPERKGI · Traditional 12/09/2022SE

Questions and answers

When was 3D-SHAPER cleared by the FDA?

3D-SHAPER (K251022) received a 510(k) decision of Substantially Equivalent on September 5, 2025, 156 days after the submission was received.

What is the product code of K251022?

The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.