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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 1993-07-23

DTX-100

Applicant Hologic, Inc.

K number K926300

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KGI 1992-11-27

MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER

Applicant Norland Corp.

K number K922286

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KGI 1992-02-27

FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM

Applicant Lunar

K number K915535

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KGI 1992-02-27

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT

Applicant Lunar

K number K914404

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KGI 1991-11-01

HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K913321

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KGI 1991-09-24

LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET

Applicant Norland Corp.

K number K913078

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KGI 1991-08-09

LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA

Applicant Lunar

K number K905291

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KGI 1991-06-10

QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K905753

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KGI 1991-05-15

QDR-1000 AND WITH X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K905691

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KGI 1991-04-29

NORLAND XR26 WHOLE BODY OPTION

Applicant Norland Corp.

K number K901804

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KGI 1990-12-05

DPX-L AND DPX-ALPHA, MODIFICATION

Applicant Lunar

K number K904980

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KGI 1990-11-23

NORLAND XR26 LATERAL SPINE OPTION

Applicant Norland Corp.

K number K902959

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KGI 1990-08-30

HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K894795

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KGI 1990-07-09

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)

Applicant Amersham Corp.

K number K901857

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KGI 1990-07-09

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

Applicant Amersham Corp.

K number K901854

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KGI 1990-07-09

GADOLINIUM-153 BONE DENSITOMETER SOURCES

Applicant Amersham Corp.

K number K901848

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KGI 1990-07-09

GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

Applicant Amersham Corp.

K number K901832

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KGI 1990-04-10

MODIFIED DPX BONE DENSITOMETER

Applicant Lunar

K number K890121

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KGI 1990-01-23

PC/QCT QUANTITATIVE SOFTWARE

Applicant The Institute For Radiological Image Sciences, Inc.

K number K896677

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KGI 1989-12-21

MODIFIED QDR-1000 X-RAY BONE DENSITOMETER

Applicant Hologic, Inc.

K number K890999

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KGI 1989-10-19

QCT BONE MINERAL DENSITY ANALYSIS SOFTWARE

Applicant Image Enhancements

K number K894854

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KGI 1989-09-12

MODIFIED OSTEOANALYZER (# SPSHA110/220)

Applicant Osteon, Inc.

K number K891582

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KGI 1989-06-23

DPX BONE DENSITOMETER FOR TOTAL BODY BONE DENSITY

Applicant Lunar

K number K884625

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KGI 1989-05-22

ND1100 BONE DENSITY SCANNER

Applicant Nuclear Data, Inc.

K number K881383

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KGI 1989-03-14

NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER

Applicant Norland Corp.

K number K881865

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KGI 1988-11-17

CSI/QCT

Applicant Columbia Scientific, Inc.

K number K880404

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KGI 1988-09-29

HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED

Applicant Hologic, Inc.

K number K883280

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KGI 1988-09-27

HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM

Applicant Hologic, Inc.

K number K883360

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KGI 1988-06-06

DPX BONE DENSITOMETER

Applicant Lunar Radiation Corp.

K number K873296

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KGI 1987-11-12

NOVO BMC-LAB 23, BONE DENSITOMETER

Applicant Scan Detectronic Laboratories, Inc.

K number K864299

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KGI 1987-10-20

HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1

Applicant Hologic, Inc.

K number K871446

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KGI 1987-10-08

X-CALIBER MODEL 1000 BONE MINERAL ANALYZER

Applicant Hologic, Inc.

K number K871553

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KGI 1987-03-09

BONE MINERAL DENSITOMETRY OPTION B7918AA

Applicant General Electric Co.

K number K863618

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KGI 1987-03-03

DUAL PHOTON BONE DENSITOMETER

Applicant Medical and Scientific Enterprises, Inc.

K number K861233

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KGI 1987-02-02

OSTEOPAK BMD (BONE MINERAL DENSITOMETER)

Applicant Siemens Gammasonics, Inc.

K number K861515

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KGI 1985-10-18

COMPUTED TOMOGRAPHY COUCH PAD FOR MIN ANALYSIS

Applicant Image Analysis, Inc.

K number K852510

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KGI 1985-10-18

QCT-BONE MINERAL PHANTOM

Applicant Image Analysis, Inc.

K number K852509

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KGI 1985-04-18

ND2100 SPINE SCANNER

Applicant Nuclear Data, Inc.

K number K844835

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KGI 1985-04-16

ND1100 BONE DENSITY SCANNER

Applicant Nuclear Data, Inc.

K number K844766

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KGI 1985-04-02

OSTEON BONE MINERAL ANALYZER

Applicant Osteon, Inc.

K number K843922

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KGI 1984-07-17

BONE DENSITOMETER

Applicant Norland Corp.

K number K841463

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KGI 1981-02-12

BONE MINERAL ANALYZER CONTROLLER

Applicant Lunar Radiation Corp.

K number K810159

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KGI 1981-02-12

DUAL-PHOTON TOTAL BODY BONE MINERAL ANA

Applicant Lunar Radiation Corp.

K number K810140

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KGI 1980-12-31

WISCONSIN BONE MINERAL ANALYZER

Applicant Lunar Radiation Corp.

K number K802181

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KGI 1980-12-31

WISCONSIN DUAL-PHOTON BONE ANALYZER

Applicant Lunar Radiation Corp.

K number K802180

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KGI 1979-12-27

NORLAND MODEL 278 BONE DENSITOMETER

Applicant Norland Corp.

K number K792444

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