KGI · Class II · 21 CFR 892.1170

FDA Product Code KGI: Densitometer, Bone

Leading manufacturers include Hologic, Inc., Lunar Corp. and Norland Corp..

148
Total
148
Cleared
156d
Avg days
1979
Since
Growing category - 5 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 202d recently vs 155d historically

FDA 510(k) Cleared Densitometer, Bone Devices (Product Code KGI)

148 devices
1–24 of 148
Cleared Sep 11, 2026
BoneVue
K254072
Curvebeam AI / Curvebeam, LLC
Radiology · 267d
Cleared Apr 20, 2026
Lunar Astra
K252718
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 235d
Cleared Sep 05, 2025
3D-SHAPER
K251022
3D-Shaper Medical S.L
Radiology · 156d
Cleared Apr 08, 2025
BunkerHill BMD
K242295
BunkerHill Health
Radiology · 249d
Cleared Jan 17, 2025
TBS iNsight (V4)
K243218
Medimaps Group SA
Radiology · 105d
Cleared May 19, 2023
VirtuOst
K220402
O.N. Diagnostics
Radiology · 462d
Cleared Dec 09, 2022
3D-SHAPER
K220822
3D-Shaper Medical S.L
Radiology · 263d
Cleared Jul 29, 2022
ABMD Software
K213760
HeartLung Corporation
Radiology · 240d
Cleared Sep 19, 2019
GEHC DXA Bone Densitometers with enCORE version 18
K191112
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 146d
Cleared Apr 20, 2018
Aria
K180782
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 25d
Cleared Dec 02, 2016
GE Lunar DXA Bone Densitometers with enCORE version 17
K161682
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Radiology · 168d
Cleared Apr 29, 2016
TBS iNsight
K152299
Medimaps Group SA
Radiology · 260d
Cleared Aug 29, 2014
QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT
K140342
Mindways Software, Inc.
Radiology · 199d
Cleared May 15, 2014
ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS
K133664
Ge Medical Systems Ultrasound & Primary Care Diagn
Radiology · 167d
Cleared May 31, 2013
SINGLE ENERGY (SE) FEMUR EXAMS
K130277
Hologic, Inc.
Radiology · 116d
Cleared Oct 05, 2012
TBS INSIGHT
K121716
Medimaps Group SA
Radiology · 116d
Cleared Sep 13, 2012
VIRTUOST
K113725
O.N. Diagnostics
Radiology · 269d
Cleared Apr 27, 2012
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS
K113286
Ge Medical Systems Lunar
Radiology · 172d
Cleared Apr 27, 2012
ACCUDXA2
K113616
Lone Oak Medical Technologies, LLC
Radiology · 142d
Cleared Mar 06, 2012
HOLOGIC VISCERAL FAT SOFTWARE
K113356
Hologic, Inc.
Radiology · 113d
Cleared May 06, 2011
GE LUNAR VISCERAL FAT SOFTWARE
K103730
Ge Medical Systems Ultrasound and Primary Care Dia
Radiology · 136d
Cleared Mar 16, 2011
NHANES WHOLE BODY DXA REFERENCE DATABASE
K103265
Hologic, Inc.
Radiology · 132d
Cleared Jun 29, 2009
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS
K091325
Cooper Surgical
Radiology · 55d
Cleared Nov 21, 2008
GE LUNAR FEMUR STRENGTH SOFTWARE
K072664
Ge Medical Systems Ultrasound and Primary Care Dia
Radiology · 428d

About Product Code KGI - Regulatory Context

510(k) Submission Activity

148 total 510(k) submissions under product code KGI since 1979, with 148 receiving FDA clearance (average review time: 156 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - KGI Product Code

Recent submissions under KGI have taken an average of 202 days to reach a decision - up from 155 days historically. Manufacturers should account for longer review timelines in current project planning.

KGI devices are reviewed by the Radiology panel. Browse all Radiology devices →