Lunar Astra

FDA 510(k) K252718 · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Substantially Equivalent

510(k) numberK252718

Submission

Device name
Lunar Astra
Applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Madison, WI, US
Received
August 28, 2025
Decision date
April 20, 2026
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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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
K161682GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional GE Medical Systems Ultrasound & Primary Care…12/02/2016SE

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

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K200158Logiq E10IYN · Traditional 04/17/2020SE
K191112GEHC DXA Bone Densitometers with enCORE version 18KGI · Traditional 09/19/2019SE
K181934Vivid T8, Vivid T9IYN · Traditional 11/06/2018SE
K180782AriaKGI · Traditional 04/20/2018SE
K170714VenueIYN · Traditional 06/21/2017SE
K170878Vivid S60N, Vivid S70NIYN · Traditional 06/14/2017SE
K161682GE Lunar DXA Bone Densitometers with enCORE version 17KGI · Traditional 12/02/2016SE

Questions and answers

When was Lunar Astra cleared by the FDA?

Lunar Astra (K252718) received a 510(k) decision of Substantially Equivalent on April 20, 2026, 235 days after the submission was received.

What is the product code of K252718?

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