TBS Insight

FDA 510(k) K121716 · Medimaps Group SA

Substantially Equivalent

510(k) numberK121716

Submission

Device name
TBS Insight
Applicant
Medimaps Group SA
Plan Les Ouates, CH
Received
June 11, 2012
Decision date
October 5, 2012
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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K2510223D-SHAPERKGI · Traditional 3D-Shaper Medical S.L09/05/2025SE
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

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

510(k)DeviceDecision
K243218TBS iNsight (V4)KGI · Traditional 01/17/2025SE
K152299TBS iNsightKGI · Traditional 04/29/2016SE

Questions and answers

When was TBS Insight cleared by the FDA?

TBS Insight (K121716) received a 510(k) decision of Substantially Equivalent on October 5, 2012, 116 days after the submission was received.

What is the product code of K121716?

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