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FDA 510(k)

GEHC DXA Bone Densitometers with enCORE version 18

K-Number: K191112 · 2019-09-19

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Decision Date2019-09-19
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GEHC DXA Bone Densitometers with enCORE version 18 is a medical device manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2019-09-19 under approval number K191112. 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 GEHC DXA Bone Densitometers with enCORE version 18?

GEHC DXA Bone Densitometers with enCORE version 18 is a medical device that received FDA 510(k) clearance on 2019-09-19. It is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K191112.

When was GEHC DXA Bone Densitometers with enCORE version 18 approved by the FDA?

GEHC DXA Bone Densitometers with enCORE version 18 received FDA 510(k) clearance on 2019-09-19, under approval number K191112.

What company makes GEHC DXA Bone Densitometers with enCORE version 18?

GEHC DXA Bone Densitometers with enCORE version 18 is manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.

What is the FDA product code for GEHC DXA Bone Densitometers with enCORE version 18?

The FDA product code for GEHC DXA Bone Densitometers with enCORE version 18 is KGI.

Other Devices by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K161682GE Lunar DXA Bone Densitometers with enCORE version 17 K161588Vscan Extend K161224LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 K153037LOGIQ V1/ LOGIQ V2 K170714Venue K170878Vivid S60N, Vivid S70N

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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 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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