Product Code: KGI FDA class 2 21 CFR 892.1170

Densitometer, Bone

Radiology

Bone Densitometer is a diagnostic imaging or measurement device used to assess bone mineral density, primarily for the diagnosis and monitoring of osteoporosis and related metabolic bone diseases, and to evaluate fracture risk in patients. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGI, regulated under 21 CFR 892.1170, within the Radiology medical specialty. This device is eligible for third-party review.

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510(k)s

147

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KGI
Device Class: FDA class 2
Regulation Number: 892.1170
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 147 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252718	Lunar Astra	Apr 20, 2026	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K251022	3D-SHAPER	Sep 05, 2025	Substantially Equivalent	3D-Shaper Medical S.L
K242295	BunkerHill BMD	Apr 08, 2025	Substantially Equivalent	BunkerHill Health
K243218	TBS iNsight (V4)	Jan 17, 2025	Substantially Equivalent	Medimaps Group SA
K220402	VirtuOst	May 19, 2023	Substantially Equivalent	O.N. Diagnostics
K220822	3D-SHAPER	Dec 09, 2022	Substantially Equivalent	3D-Shaper Medical S.L
K213760	ABMD Software	Jul 29, 2022	Substantially Equivalent	HeartLung Corporation
K191112	GEHC DXA Bone Densitometers with enCORE version 18	Sep 19, 2019	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K180782	Aria	Apr 20, 2018	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K161682	GE Lunar DXA Bone Densitometers with enCORE version 17	Dec 02, 2016	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
K152299	TBS iNsight	Apr 29, 2016	Substantially Equivalent	Medimaps Group SA
K140342	QCT PRO ASYNCHRONOUS CALIBRATION MODULE, CLINIQCT	Aug 29, 2014	Substantially Equivalent	Mindways Software, Inc.
K133664	ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS	May 15, 2014	Substantially Equivalent	Ge Medical Systems Ultrasound & Primary Care Diagn
K130277	SINGLE ENERGY (SE) FEMUR EXAMS	May 31, 2013	Substantially Equivalent	Hologic, Inc.
K121716	TBS INSIGHT	Oct 05, 2012	Substantially Equivalent	Medimaps Group SA
K113725	VIRTUOST	Sep 13, 2012	Substantially Equivalent	O.N. Diagnostics
K113616	ACCUDXA2	Apr 27, 2012	Substantially Equivalent	Lone Oak Medical Technologies, LLC
K113286	ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS	Apr 27, 2012	Substantially Equivalent	Ge Medical Systems Lunar
K113356	HOLOGIC VISCERAL FAT SOFTWARE	Mar 06, 2012	Substantially Equivalent	Hologic, Inc.
K103730	GE LUNAR VISCERAL FAT SOFTWARE	May 06, 2011	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia
K103265	NHANES WHOLE BODY DXA REFERENCE DATABASE	Mar 16, 2011	Substantially Equivalent	Hologic, Inc.
K091325	TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS	Jun 29, 2009	Substantially Equivalent	Cooper Surgical
K072664	GE LUNAR FEMUR STRENGTH SOFTWARE	Nov 21, 2008	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia
K082402	OSDX HIP BMD SYSTEM	Oct 16, 2008	Substantially Equivalent	Imaging Therapeutics, Inc.
K082317	GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION	Sep 26, 2008	Substantially Equivalent	General Electric Co.
K080711	1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION	Sep 02, 2008	Substantially Equivalent	Hologic, Inc.
K072847	APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS	Mar 28, 2008	Substantially Equivalent	Hologic, Inc.
K072439	GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT	Sep 14, 2007	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia
K071570	GE LUNAR BODY COMPOSITION SOFTWARE	Jun 27, 2007	Substantially Equivalent	Ge Medical Systems Lunar
K061561	HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS	Jul 28, 2006	Substantially Equivalent	Hologic, Inc.
K060111	IVA (MXA II SOFTWARE OPTION)	Apr 24, 2006	Substantially Equivalent	Hologic, Inc.
K052581	LUNAR IDXA	Oct 20, 2005	Substantially Equivalent	Ge Medical Systems Ultrasound and Primary Care Dia
K042480	INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS	Oct 29, 2004	Substantially Equivalent	Hologic, Inc.
K041266	PEDIATRIC REFERENCE DATABASE	Aug 11, 2004	Substantially Equivalent	Hologic, Inc.
K033550	DXL CALSCAN	May 05, 2004	Substantially Equivalent	Demetech AB
K033224	HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER	Nov 05, 2003	Substantially Equivalent	Hologic, Inc.
K031991	DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS	Jul 30, 2003	Substantially Equivalent	Image Analysis, Inc.
K030962	DPX SERIES BRAVO DUO BONE DENSITOMETER	Jul 25, 2003	Substantially Equivalent	Ge Lunar Corp.
K030330	CTXA HIP EXTENDED REFERENCE DATA	Jun 20, 2003	Substantially Equivalent	Mindways Software, Inc.
K023554	DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE	Dec 20, 2002	Substantially Equivalent	Ge Lunar Corp.
K023398	HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY	Nov 08, 2002	Substantially Equivalent	Hologic, Inc.
K021527	SECTRA OSTEOPOROSIS PACKAGE	Jun 07, 2002	Substantially Equivalent	Sectra-Imtec AB
K021331	DEXACARE G4	May 21, 2002	Substantially Equivalent	Osteometer Meditech, Inc.
K002113	CTXA HIP; CTXA; QCT PRO CTXA HIP	Dec 04, 2001	Substantially Equivalent	Mindways Software, Inc.
K011917	ADVANCED HIP ASSESSMENT SOFTWARE	Aug 03, 2001	Substantially Equivalent	Ge Lunar Corp.
K003656	X-POSURE SYSTEM VERSION 2 MAMMO	Dec 15, 2000	Substantially Equivalent	Pronosco A/S
K002500	X-POSURE SYSTEM VERSION 2 RAD	Oct 23, 2000	Substantially Equivalent	Pronosco A/S
K002711	HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER	Sep 28, 2000	Substantially Equivalent	Hologic, Inc.
K001812	PEDIATRIC REFERENCE DATA	Jul 10, 2000	Substantially Equivalent	Lunar Corp.
K001756	LUNAR REPORT GENERATOR II	Jul 06, 2000	Substantially Equivalent	Lunar Corp.
K993176	MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY	Jun 20, 2000	Substantially Equivalent	Norland Medical Systems, Inc.
K001429	MODIFICATION TO ACCUDEXA BONE DENSITOMETER	May 26, 2000	Substantially Equivalent	Schick Technologies, Inc.
K993337	APOLLO MULTI-RACIAL REFERENCE POPULATION	May 16, 2000	Substantially Equivalent	Norland Medical Systems, Inc.
K000162	METRISCAN BONE DENSITY SYSTEM	May 12, 2000	Substantially Equivalent	Alara, Inc.
K000826	PRODIGY LATERAL VIEW SOFTWARE	Apr 14, 2000	Substantially Equivalent	Lunar Corp.
K992125	XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46	Nov 22, 1999	Substantially Equivalent	Norland Medical Systems, Inc.
K992775	OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W	Oct 01, 1999	Substantially Equivalent	Hologic, Inc.
K992677	EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W	Sep 03, 1999	Substantially Equivalent	Hologic, Inc.
K992246	QCT BONE MINERAL ANALYSIS SOFTWARE	Sep 03, 1999	Substantially Equivalent	Image Analysis, Inc.
K984285	OSTEOGRAM BONE DENSITOMETER	May 19, 1999	Substantially Equivalent	Compumed, Inc.
K984178	PRONOSCO X-POSURE SYSTEM	Feb 18, 1999	Substantially Equivalent	Torsana Osteoporosis Diagnostics A/S
K983724	ORCA-DX BONE DENSITOMETER	Dec 08, 1998	Substantially Equivalent	Lunar Corp.
K983564	PRODIGY TOTAL BODY SOFTWARE	Dec 08, 1998	Substantially Equivalent	Lunar Corp.
K983271	FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS	Nov 18, 1998	Substantially Equivalent	Lunar Corp.
K983269	FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER	Nov 18, 1998	Substantially Equivalent	Lunar Corp.
K983262	FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS	Nov 18, 1998	Substantially Equivalent	Lunar Corp.
K983028	FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W	Nov 13, 1998	Substantially Equivalent	Hologic, Inc.
K983273	XCT 2000 L PQCT BONE DENSITOMETER	Oct 29, 1998	Substantially Equivalent	Medical Systems, Inc.
K982267	DPX-RX BONE DENSITOMETER	Aug 18, 1998	Substantially Equivalent	Lunar Corp.
K980569	FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS	Jun 12, 1998	Substantially Equivalent	Norland Corp.
K980289	FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER	Jun 12, 1998	Substantially Equivalent	Norland Corp.
K981124	ACCUDEXA BONE DENSITOMETER	Jun 04, 1998	Substantially Equivalent	Schick Technologies, Inc.
K980125	REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER	May 20, 1998	Substantially Equivalent	Norland Corp.
K974437	EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE	Feb 13, 1998	Substantially Equivalent	Lunar Corp.
K973459	NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS	Feb 13, 1998	Substantially Equivalent	Norland Corp.
K973104	NORLAND MODEL PDEXA BONE DENSITOMETER	Jan 29, 1998	Substantially Equivalent	Norland Corp.
K971735	ACCUDEXA BONE DENSITOMETER	Dec 02, 1997	Substantially Equivalent	Schick Technologies, Inc.
K972517	EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE	Nov 18, 1997	Substantially Equivalent	Lunar Corp.
K972882	APOLLO	Oct 31, 1997	Substantially Equivalent	Norland Corp.
K964562	DTX-200 BONE DENSITOMETER	Aug 22, 1997	Substantially Equivalent	Osteometer Meditech A/S
K972053	PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM	Aug 08, 1997	Substantially Equivalent	Lunar Corp.
K963789	DTX-100 BONE DENSITOMETER	Jul 14, 1997	Substantially Equivalent	Osteometer Meditech A/S
K961787	BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS	Jun 13, 1997	Substantially Equivalent	Hologic, Inc.
K970224	PIXI BONE DENSITOMETER	Apr 16, 1997	Substantially Equivalent	Lunar Corp.
K964307	EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS	Apr 16, 1997	Substantially Equivalent	Lunar Corp.
K963363	HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS	Nov 22, 1996	Substantially Equivalent	Hologic, Inc.
K964263	EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE	Nov 07, 1996	Substantially Equivalent	Lunar Corp.
K961007	EXPERT SPINE MORPHOTIETRY REFERENCE	Jul 25, 1996	Substantially Equivalent	Lunar Corp.
K961011	DTX-200 BONE DENSITOMETER	Jul 05, 1996	Substantially Equivalent	Shotwell & Carr, Inc.
K961944	LUNAR REPORT GENERATOR	Jul 03, 1996	Substantially Equivalent	Lunar Corp.
K953032	LUNAR DPX DENSITOMETER	Oct 23, 1995	Substantially Equivalent	Lunar Corp.
K941362	BONE MINERAL DENSITOMETER	Aug 30, 1995	Substantially Equivalent	Hologic, Inc.
K952060	QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000	Jun 05, 1995	Substantially Equivalent	Image Analysis, Inc.
K950611	EXPERT MORPHOMERTY SOFTWARD	May 24, 1995	Substantially Equivalent	Lunar Corp.
K941127	QCT-BONE MINERAL ANALYSIS SOFTWARE	May 11, 1995	Substantially Equivalent	Image Analysis, Inc.
K941126	QCT-BONE MINERAL ANALYSIS PHANTOM	May 03, 1995	Substantially Equivalent	Image Analysis, Inc.
K945526	LUNAR EXPERT	Apr 25, 1995	Substantially Equivalent	Lunar Corp.
K931996	MODEL PDEXA BONE DENSITOMETER	Feb 01, 1995	Substantially Equivalent	Norland Corp.
K943505	HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER	Jan 20, 1995	Substantially Equivalent	Hologic, Inc.
K934040	THE OSTEOREPORT	Sep 26, 1994	Substantially Equivalent	Woodson and Associates, LLC
K926019	FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET	Sep 23, 1994	Substantially Equivalent	Norland Corp.
K926300	DTX-100	Jul 23, 1993	Substantially Equivalent	Hologic, Inc.
K922286	MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER	Nov 27, 1992	Substantially Equivalent	Norland Corp.
K915535	FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM	Feb 27, 1992	Substantially Equivalent	Lunar
K914404	ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT	Feb 27, 1992	Substantially Equivalent	Lunar
K913321	HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER	Nov 01, 1991	Substantially Equivalent	Hologic, Inc.
K913078	LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET	Sep 24, 1991	Substantially Equivalent	Norland Corp.
K905291	LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA	Aug 09, 1991	Substantially Equivalent	Lunar
K905753	QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER	Jun 10, 1991	Substantially Equivalent	Hologic, Inc.
K905691	QDR-1000 AND WITH X-RAY BONE DENSITOMETER	May 15, 1991	Substantially Equivalent	Hologic, Inc.
K901804	NORLAND XR26 WHOLE BODY OPTION	Apr 29, 1991	Substantially Equivalent	Norland Corp.
K904980	DPX-L AND DPX-ALPHA, MODIFICATION	Dec 05, 1990	Substantially Equivalent	Lunar
K902959	NORLAND XR26 LATERAL SPINE OPTION	Nov 23, 1990	Substantially Equivalent	Norland Corp.
K894795	HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER	Aug 30, 1990	Substantially Equivalent	Hologic, Inc.
K901857	GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)	Jul 09, 1990	Substantially Equivalent	Amersham Corp.
K901854	GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)	Jul 09, 1990	Substantially Equivalent	Amersham Corp.
K901848	GADOLINIUM-153 BONE DENSITOMETER SOURCES	Jul 09, 1990	Substantially Equivalent	Amersham Corp.
K901832	GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415	Jul 09, 1990	Substantially Equivalent	Amersham Corp.
K890121	MODIFIED DPX BONE DENSITOMETER	Apr 10, 1990	Substantially Equivalent	Lunar
K896677	PC/QCT QUANTITATIVE SOFTWARE	Jan 23, 1990	Substantially Equivalent	The Institute For Radiological Image Sciences, Inc.
K890999	MODIFIED QDR-1000 X-RAY BONE DENSITOMETER	Dec 21, 1989	Substantially Equivalent	Hologic, Inc.
K894854	QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE	Oct 19, 1989	Substantially Equivalent	Image Enhancements
K891582	MODIFIED OSTEOANALYZER (# SPSHA110/220)	Sep 12, 1989	Substantially Equivalent	Osteon, Inc.
K884625	DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY	Jun 23, 1989	Substantially Equivalent	Lunar
K881383	ND1100 BONE DENSITY SCANNER	May 22, 1989	Substantially Equivalent	Nuclear Data, Inc.
K881865	NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER	Mar 14, 1989	Substantially Equivalent	Norland Corp.
K880404	CSI/QCT	Nov 17, 1988	Substantially Equivalent	Columbia Scientific, Inc.
K883280	HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED	Sep 29, 1988	Substantially Equivalent	Hologic, Inc.
K883360	HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM	Sep 27, 1988	Substantially Equivalent	Hologic, Inc.
K873296	DPX BONE DENSITOMETER	Jun 06, 1988	Substantially Equivalent	Lunar Radiation Corp.
K864299	NOVO BMC-LAB 23, BONE DENSITOMETER	Nov 12, 1987	Substantially Equivalent	Scan Detectronic Laboratories, Inc.
K871446	HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1	Oct 20, 1987	Substantially Equivalent	Hologic, Inc.
K871553	X-CALIBER MODEL 1000 BONE MINERAL ANALYZER	Oct 08, 1987	Substantially Equivalent	Hologic, Inc.
K863618	BONE MINERAL DENSITOMETRY OPTION B7918AA	Mar 09, 1987	Substantially Equivalent	General Electric Co.
K861233	DUAL PHOTON BONE DENSITOMETER	Mar 03, 1987	Substantially Equivalent	Medical and Scientific Enterprises, Inc.
K861515	OSTEOPAK BMD (BONE MINERAL DENSITOMETER)	Feb 02, 1987	Substantially Equivalent	Siemens Gammasonics, Inc.
K852510	COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS	Oct 18, 1985	Substantially Equivalent	Image Analysis, Inc.
K852509	QCT-BONE MINERAL PHANTOM	Oct 18, 1985	Substantially Equivalent	Image Analysis, Inc.
K844835	ND2100 SPINE SCANNER	Apr 18, 1985	Substantially Equivalent	Nuclear Data, Inc.
K844766	ND1100 BONE DENSITY SCANNER	Apr 16, 1985	Substantially Equivalent	Nuclear Data, Inc.
K843922	OSTEON BONE MINERAL ANALYZER	Apr 02, 1985	Substantially Equivalent	Osteon, Inc.
K841463	BONE DENSITOMETER	Jul 17, 1984	Substantially Equivalent	Norland Corp.
K810159	BONE MINERAL ANALYZER CONTROLLER	Feb 12, 1981	Substantially Equivalent	Lunar Radiation Corp.
K810140	DUAL-PHOTON TOTAL BODY BONE MINERAL ANA	Feb 12, 1981	Substantially Equivalent	Lunar Radiation Corp.
K802181	WISCONSIN BONE MINERAL ANALYZER	Dec 31, 1980	Substantially Equivalent	Lunar Radiation Corp.
K802180	WISCONSIN DUAL-PHOTON BONE ANALYZER	Dec 31, 1980	Substantially Equivalent	Lunar Radiation Corp.
K792444	NORLAND MODEL 278 BONE DENSITOMETER	Dec 27, 1979	Substantially Equivalent	Norland Corp.