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FDA 510(k)

TBS iNsight (V4)

K-Number: K243218 · 2025-01-17

ApplicantMedimaps Group SA
Decision Date2025-01-17
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TBS iNsight (V4) is a medical device manufactured by Medimaps Group SA. It received FDA 510(k) clearance on 2025-01-17 under approval number K243218. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TBS iNsight (V4)?

TBS iNsight (V4) is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Medimaps Group SA. The 510(k) number is K243218.

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

TBS iNsight (V4) received FDA 510(k) clearance on 2025-01-17, under approval number K243218.

What company makes TBS iNsight (V4)?

TBS iNsight (V4) is manufactured by Medimaps Group SA.

What is the FDA product code for TBS iNsight (V4)?

The FDA product code for TBS iNsight (V4) is KGI.

Other Devices by Medimaps Group SA

K152299TBS iNsight

Related Devices (Code: KGI)

K161682GE Lunar DXA Bone Densitometers with enCORE version 17GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K152299TBS iNsightMedimaps Group SA K180782AriaGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K191112GEHC DXA Bone Densitometers with enCORE version 18GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC K2208223D-SHAPER3D-Shaper Medical S.L K213760ABMD SoftwareHeartLung Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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