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FDA 510(k)

GE Lunar DXA Bone Densitometers with enCORE version 17

K-Number: K161682 · 2016-12-02

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Decision Date2016-12-02
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE Lunar DXA Bone Densitometers with enCORE version 17 is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2016-12-02 under approval number K161682. 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 GE Lunar DXA Bone Densitometers with enCORE version 17?

GE Lunar DXA Bone Densitometers with enCORE version 17 is a medical device that received FDA 510(k) clearance on 2016-12-02. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K161682.

When was GE Lunar DXA Bone Densitometers with enCORE version 17 approved by the FDA?

GE Lunar DXA Bone Densitometers with enCORE version 17 received FDA 510(k) clearance on 2016-12-02, under approval number K161682.

What company makes GE Lunar DXA Bone Densitometers with enCORE version 17?

GE Lunar DXA Bone Densitometers with enCORE version 17 is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.

What is the FDA product code for GE Lunar DXA Bone Densitometers with enCORE version 17?

The FDA product code for GE Lunar DXA Bone Densitometers with enCORE version 17 is KGI.

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Related Devices (Code: KGI)

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 K220402VirtuOstO.N. Diagnostics

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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