TBS iNsight (V4)

FDA 510(k) K243218 · Medimaps Group SA

Substantially Equivalent

510(k) numberK243218

Submission

Device name
TBS iNsight (V4)
Applicant
Medimaps Group SA
Plan-Les-Ouates, CH
Received
October 4, 2024
Decision date
January 17, 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

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K220402VirtuOstKGI · Traditional O.N. Diagnostics05/19/2023SE
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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
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More from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

510(k)DeviceDecision
K152299TBS iNsightKGI · Traditional 04/29/2016SE
K121716TBS InsightKGI · Traditional 10/05/2012SE

Questions and answers

When was TBS iNsight (V4) cleared by the FDA?

TBS iNsight (V4) (K243218) received a 510(k) decision of Substantially Equivalent on January 17, 2025, 105 days after the submission was received.

What is the product code of K243218?

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