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
148 devices
73–96 of 148
Cleared Jun 04, 1998
ACCUDEXA BONE DENSITOMETER
K981124
Schick Technologies, Inc.
Radiology · 69d
Cleared May 20, 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125
Norland Corp.
Radiology · 126d
Cleared Feb 13, 1998
NORLAND BODY COMPOSITION OPTION FOR NORLAND DEXA BONE DENSITOMETERS
K973459
Norland Corp.
Radiology · 154d
Cleared Feb 13, 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437
Lunar Corp.
Radiology · 81d
Cleared Jan 29, 1998
NORLAND MODEL PDEXA BONE DENSITOMETER
K973104
Norland Corp.
Radiology · 163d
Cleared Dec 02, 1997
ACCUDEXA BONE DENSITOMETER
K971735
Schick Technologies, Inc.
Radiology · 204d
Cleared Nov 18, 1997
EXPERT-XL ORTHOPEDIC HIP ACQUISITION AND ANALYSIS SOFTWARE
K972517
Lunar Corp.
Radiology · 134d
Cleared Oct 31, 1997
APOLLO
K972882
Norland Corp.
Radiology · 87d
Cleared Aug 22, 1997
DTX-200 BONE DENSITOMETER
K964562
Osteometer Meditech A/S
Radiology · 282d
Cleared Aug 08, 1997
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
K972053
Lunar Corp.
Radiology · 67d
Cleared Jul 14, 1997
DTX-100 BONE DENSITOMETER
K963789
Osteometer Meditech A/S
Radiology · 297d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787
Hologic, Inc.
Radiology · 400d
Cleared Apr 16, 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307
Lunar Corp.
Radiology · 169d
Cleared Apr 16, 1997
PIXI BONE DENSITOMETER
K970224
Lunar Corp.
Radiology · 85d
Cleared Nov 22, 1996
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363
Hologic, Inc.
Radiology · 87d
Cleared Nov 07, 1996
EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
K964263
Lunar Corp.
Radiology · 13d
Cleared Jul 25, 1996
EXPERT SPINE MORPHOTIETRY REFERENCE
K961007
Lunar Corp.
Radiology · 135d
Cleared Jul 05, 1996
DTX-200 BONE DENSITOMETER
K961011
Shotwell & Carr, Inc.
Radiology · 114d
Cleared Jul 03, 1996
LUNAR REPORT GENERATOR
K961944
Lunar Corp.
Radiology · 44d
Cleared Oct 23, 1995
LUNAR DPX DENSITOMETER
K953032
Lunar Corp.
Radiology · 115d
Cleared Aug 30, 1995
BONE MINERAL DENSITOMETER
K941362
Hologic, Inc.
Radiology · 527d
Cleared Jun 05, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000
K952060
Image Analysis, Inc.
Radiology · 34d
Cleared May 24, 1995
EXPERT MORPHOMERTY SOFTWARD
K950611
Lunar Corp.
Radiology · 103d
Cleared May 11, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE
K941127
Image Analysis, Inc.
Radiology · 428d