BunkerHill BMD

FDA 510(k) K242295 · BunkerHill Health

Substantially Equivalent

510(k) numberK242295

Submission

Device name
BunkerHill BMD
Applicant
BunkerHill Health
San Francisco, CA, US
Received
August 2, 2024
Decision date
April 8, 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

Other 510(k)s with product code KGI

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K2510223D-SHAPERKGI · Traditional 3D-Shaper Medical S.L09/05/2025SE
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

510(k)DeviceDecision
K260167Bunkerhill Contrast AVCJAK · Traditional 03/06/2026SE
K260166Bunkerhill Contrast CACJAK · Traditional 03/06/2026SE
K250662Bunkerhill MACJAK · Traditional 10/03/2025SE
K250649Bunkerhill ECG-EFQYE · Traditional 09/19/2025SE
K243779Bunkerhill Abdominal Aortic Quantification (AAQ)QIH · Traditional 07/01/2025SE
K243229Bunkerhill AVCJAK · Traditional 01/27/2025SE
K240369CAC (gated) AlgorithmJAK · Traditional 09/27/2024SE

Questions and answers

When was BunkerHill BMD cleared by the FDA?

BunkerHill BMD (K242295) received a 510(k) decision of Substantially Equivalent on April 8, 2025, 249 days after the submission was received.

What is the product code of K242295?

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