FDA.report

510(k) K251022

Device
3D-SHAPER
Applicant
3D-Shaper Medical S.L
510(k) number
K251022
Product code
KGI
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-05
Date received
2025-04-02
Regulation
892.1170
Classification name
Densitometer, Bone
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ludovic Humbert
Address
Rambla Catalunya, 53, 4-H Barcelona ES 08007 08007

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code KGI

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K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2026-04-20
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K243218TBS iNsight (V4)Medimaps Group SA2025-01-17
K220402VirtuOstO.N. Diagnostics2023-05-19
K2208223D-SHAPER3D-Shaper Medical S.L2022-12-09
K213760ABMD SoftwareHeartLung Corporation2022-07-29
K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2019-09-19
K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2018-04-20
K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC2016-12-02
K152299TBS iNsightMedimaps Group SA2016-04-29
K140342QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCTMindways Software, Inc.2014-08-29
K133664ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERSGe Medical Systems Ultrasound & Primary Care Diagn2014-05-15
K130277SINGLE ENERGY (SE) FEMUR EXAMSHologic, Inc.2013-05-31
K121716TBS INSIGHTMedimaps Group SA2012-10-05
K113725VIRTUOSTO.N. Diagnostics2012-09-13