Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Densitometer, Bone

FDA product code KGI · 146 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1170
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1979-12-27 – 2026-09-11

KGI 2026-09-11

BoneVue

Applicant Curvebeam AI / Curvebeam, LLC

K number K254072

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KGI 2026-04-20

Lunar Astra

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K number K252718

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KGI 2025-09-05

3D-SHAPER

Applicant 3D-Shaper Medical S.L

K number K251022

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KGI 2025-04-08

BunkerHill BMD

Applicant BunkerHill Health

K number K242295

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KGI 2025-01-17

TBS iNsight (V4)

Applicant Medimaps Group SA

K number K243218

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KGI 2023-05-19

VirtuOst

Applicant O.N. Diagnostics

K number K220402

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KGI 2022-12-09

3D-SHAPER

Applicant 3D-Shaper Medical S.L

K number K220822

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KGI 2022-07-29

ABMD Software

Applicant HeartLung Corporation

K number K213760

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KGI 2019-09-19

GEHC DXA Bone Densitometers with enCORE version 18

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K number K191112

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KGI 2018-04-20

Aria

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K number K180782

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KGI 2016-12-02

GE Lunar DXA Bone Densitometers with enCORE version 17

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K number K161682

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KGI 2016-04-29

TBS iNsight

Applicant Medimaps Group SA

K number K152299

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KGI 2013-05-31

SINGLE ENERGY (SE) FEMUR EXAMS

Applicant Hologic, Inc.

K number K130277

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KGI 2012-10-05

TBS INSIGHT

Applicant Medimaps Group SA

K number K121716

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KGI 2012-09-13

VIRTUOST

Applicant O.N. Diagnostics

K number K113725

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KGI 2012-04-27

ACCUDXA2

Applicant Lone Oak Medical Technologies, LLC

K number K113616

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KGI 2012-04-27

ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

Applicant Ge Medical Systems Lunar

K number K113286

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KGI 2012-03-06

HOLOGIC VISCERAL FAT SOFTWARE

Applicant Hologic, Inc.

K number K113356

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KGI 2011-05-06

GE LUNAR VISCERAL FAT SOFTWARE

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K103730

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KGI 2011-03-16

NHANES WHOLE BODY DXA REFERENCE DATABASE

Applicant Hologic, Inc.

K number K103265

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KGI 2009-06-29

TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS

Applicant Cooper Surgical

K number K091325

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KGI 2008-11-21

GE LUNAR FEMUR STRENGTH SOFTWARE

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K072664

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KGI 2008-10-16

OSDX HIP BMD SYSTEM

Applicant Imaging Therapeutics, Inc.

K number K082402

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KGI 2008-09-26

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION

Applicant General Electric Co.

K number K082317

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KGI 2008-09-02

1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION

Applicant Hologic, Inc.

K number K080711

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KGI 2008-03-28

APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS

Applicant Hologic, Inc.

K number K072847

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KGI 2007-09-14

GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K072439

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KGI 2007-06-27

GE LUNAR BODY COMPOSITION SOFTWARE

Applicant Ge Medical Systems Lunar

K number K071570

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KGI 2006-07-28

HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS

Applicant Hologic, Inc.

K number K061561

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KGI 2006-04-24

IVA (MXA II SOFTWARE OPTION)

Applicant Hologic, Inc.

K number K060111

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KGI 2005-10-20

LUNAR IDXA

Applicant Ge Medical Systems Ultrasound and Primary Care Dia

K number K052581

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KGI 2004-10-29

INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS

Applicant Hologic, Inc.

K number K042480

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KGI 2004-08-11

PEDIATRIC REFERENCE DATABASE

Applicant Hologic, Inc.

K number K041266

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KGI 2004-05-05

DXL CALSCAN

Applicant Demetech AB

K number K033550

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KGI 2003-11-05

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

Applicant Hologic, Inc.

K number K033224

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KGI 2003-07-30

DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS

Applicant Image Analysis, Inc.

K number K031991

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KGI 2003-07-25

DPX SERIES BRAVO DUO BONE DENSITOMETER

Applicant Ge Lunar Corp.

K number K030962

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KGI 2003-06-20

CTXA HIP EXTENDED REFERENCE DATA

Applicant Mindways Software, Inc.

K number K030330

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KGI 2002-12-20

DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE

Applicant Ge Lunar Corp.

K number K023554

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KGI 2002-11-08

HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY

Applicant Hologic, Inc.

K number K023398

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KGI 2002-06-07

SECTRA OSTEOPOROSIS PACKAGE

Applicant Sectra-Imtec AB

K number K021527

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KGI 2002-05-21

DEXACARE G4

Applicant Osteometer Meditech, Inc.

K number K021331

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KGI 2001-12-04

CTXA HIP; CTXA; QCT PRO CTXA HIP

Applicant Mindways Software, Inc.

K number K002113

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KGI 2001-08-03

ADVANCED HIP ASSESSMENT SOFTWARE

Applicant Ge Lunar Corp.

K number K011917

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KGI 2000-12-15

X-POSURE SYSTEM VERSION 2 MAMMO

Applicant Pronosco A/S

K number K003656

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KGI 2000-10-23

X-POSURE SYSTEM VERSION 2 RAD

Applicant Pronosco A/S

K number K002500

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KGI 2000-09-28

HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K002711

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KGI 2000-07-10

PEDIATRIC REFERENCE DATA

Applicant Lunar Corp.

K number K001812

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KGI 2000-07-06

LUNAR REPORT GENERATOR II

Applicant Lunar Corp.

K number K001756

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KGI 2000-06-20

MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY

Applicant Norland Medical Systems, Inc.

K number K993176

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KGI 2000-05-26

MODIFICATION TO ACCUDEXA BONE DENSITOMETER

Applicant Schick Technologies, Inc.

K number K001429

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KGI 2000-05-16

APOLLO MULTI-RACIAL REFERENCE POPULATION

Applicant Norland Medical Systems, Inc.

K number K993337

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KGI 2000-05-12

METRISCAN BONE DENSITY SYSTEM

Applicant Alara, Inc.

K number K000162

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KGI 2000-04-14

PRODIGY LATERAL VIEW SOFTWARE

Applicant Lunar Corp.

K number K000826

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KGI 1999-11-22

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46

Applicant Norland Medical Systems, Inc.

K number K992125

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KGI 1999-10-01

OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

Applicant Hologic, Inc.

K number K992775

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KGI 1999-09-03

EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

Applicant Hologic, Inc.

K number K992677

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KGI 1999-09-03

QCT BONE MINERAL ANALYSIS SOFTWARE

Applicant Image Analysis, Inc.

K number K992246

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KGI 1999-05-19

OSTEOGRAM BONE DENSITOMETER

Applicant Compumed, Inc.

K number K984285

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KGI 1999-02-18

PRONOSCO X-POSURE SYSTEM

Applicant Torsana Osteoporosis Diagnostics A/S

K number K984178

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KGI 1998-12-08

ORCA-DX BONE DENSITOMETER

Applicant Lunar Corp.

K number K983724

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KGI 1998-12-08

PRODIGY TOTAL BODY SOFTWARE

Applicant Lunar Corp.

K number K983564

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KGI 1998-11-18

FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS

Applicant Lunar Corp.

K number K983271

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KGI 1998-11-18

FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER

Applicant Lunar Corp.

K number K983269

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KGI 1998-11-18

FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS

Applicant Lunar Corp.

K number K983262

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KGI 1998-11-13

FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W

Applicant Hologic, Inc.

K number K983028

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KGI 1998-10-29

XCT 2000 L PQCT BONE DENSITOMETER

Applicant Medical Systems, Inc.

K number K983273

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KGI 1998-08-18

DPX-RX BONE DENSITOMETER

Applicant Lunar Corp.

K number K982267

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KGI 1998-06-12

FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS

Applicant Norland Corp.

K number K980569

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KGI 1998-06-12

FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER

Applicant Norland Corp.

K number K980289

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KGI 1998-06-04

ACCUDEXA BONE DENSITOMETER

Applicant Schick Technologies, Inc.

K number K981124

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KGI 1998-05-20

REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER

Applicant Norland Corp.

K number K980125

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KGI 1998-02-13

EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE

Applicant Lunar Corp.

K number K974437

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KGI 1998-02-13

NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS

Applicant Norland Corp.

K number K973459

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KGI 1998-01-29

NORLAND MODEL PDEXA BONE DENSITOMETER

Applicant Norland Corp.

K number K973104

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KGI 1997-12-02

ACCUDEXA BONE DENSITOMETER

Applicant Schick Technologies, Inc.

K number K971735

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KGI 1997-11-18

EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE

Applicant Lunar Corp.

K number K972517

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KGI 1997-10-31

APOLLO

Applicant Norland Corp.

K number K972882

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KGI 1997-08-22

DTX-200 BONE DENSITOMETER

Applicant Osteometer Meditech A/S

K number K964562

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KGI 1997-08-08

PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM

Applicant Lunar Corp.

K number K972053

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KGI 1997-07-14

DTX-100 BONE DENSITOMETER

Applicant Osteometer Meditech A/S

K number K963789

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KGI 1997-06-13

BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS

Applicant Hologic, Inc.

K number K961787

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KGI 1997-04-16

PIXI BONE DENSITOMETER

Applicant Lunar Corp.

K number K970224

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KGI 1997-04-16

EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS

Applicant Lunar Corp.

K number K964307

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KGI 1996-11-22

HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS

Applicant Hologic, Inc.

K number K963363

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KGI 1996-11-07

EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE

Applicant Lunar Corp.

K number K964263

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KGI 1996-07-25

EXPERT SPINE MORPHOTIETRY REFERENCE

Applicant Lunar Corp.

K number K961007

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KGI 1996-07-05

DTX-200 BONE DENSITOMETER

Applicant Shotwell & Carr, Inc.

K number K961011

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KGI 1996-07-03

LUNAR REPORT GENERATOR

Applicant Lunar Corp.

K number K961944

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KGI 1995-10-23

LUNAR DPX DENSITOMETER

Applicant Lunar Corp.

K number K953032

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KGI 1995-08-30

BONE MINERAL DENSITOMETER

Applicant Hologic, Inc.

K number K941362

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KGI 1995-06-05

QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000

Applicant Image Analysis, Inc.

K number K952060

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KGI 1995-05-24

EXPERT MORPHOMERTY SOFTWARD

Applicant Lunar Corp.

K number K950611

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KGI 1995-05-11

QCT-BONE MINERAL ANALYSIS SOFTWARE

Applicant Image Analysis, Inc.

K number K941127

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KGI 1995-05-03

QCT-BONE MINERAL ANALYSIS PHANTOM

Applicant Image Analysis, Inc.

K number K941126

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KGI 1995-04-25

LUNAR EXPERT

Applicant Lunar Corp.

K number K945526

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KGI 1995-02-01

MODEL PDEXA BONE DENSITOMETER

Applicant Norland Corp.

K number K931996

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KGI 1995-01-20

HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K943505

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KGI 1994-09-26

THE OSTEOREPORT

Applicant Woodson and Associates, LLC

K number K934040

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KGI 1994-09-23

FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET

Applicant Norland Corp.

K number K926019

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