KGI · Class II · 21 CFR 892.1170

FDA Product Code KGI: Densitometer, Bone

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

147
Total
147
Cleared
155d
Avg days
1979
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Review times increasing: avg 186d recently vs 155d historically

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

147 devices
1–24 of 147
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 Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317
General Electric Co.
Radiology · 44d
Cleared Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
K080711
Hologic, Inc.
Radiology · 173d
Cleared Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
K072847
Hologic, Inc.
Radiology · 176d

About Product Code KGI - Regulatory Context

510(k) Submission Activity

147 total 510(k) submissions under product code KGI since 1979, with 147 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 4 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 186 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 →