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
97–120 of 148
Cleared May 03, 1995
QCT-BONE MINERAL ANALYSIS PHANTOM
K941126
Image Analysis, Inc.
Radiology · 420d
Cleared Apr 25, 1995
LUNAR EXPERT
K945526
Lunar Corp.
Radiology · 166d
Cleared Feb 01, 1995
MODEL PDEXA BONE DENSITOMETER
K931996
Norland Corp.
Radiology · 649d
Cleared Jan 20, 1995
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505
Hologic, Inc.
Radiology · 184d
Cleared Sep 26, 1994
THE OSTEOREPORT
K934040
Woodson and Associates, LLC
Radiology · 404d
Cleared Sep 23, 1994
FORARM OPT/NORLAND XR SERIES X-RAY BONE DENSITOMET
K926019
Norland Corp.
Radiology · 662d
Cleared Jul 23, 1993
DTX-100
K926300
Hologic, Inc.
Radiology · 221d
Cleared Nov 27, 1992
MODEL XCT-900 PQCT X-RAY BONE DENSITOMETER
K922286
Norland Corp.
Radiology · 196d
Cleared Feb 27, 1992
ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT
K914404
Lunar
Radiology · 147d
Cleared Feb 27, 1992
FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM
K915535
Lunar
Radiology · 80d
Cleared Nov 01, 1991
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321
Hologic, Inc.
Radiology · 99d
Cleared Sep 24, 1991
LATERAL SPINE OPT. XR-SERIES X-RAY BONE DENSITOMET
K913078
Norland Corp.
Radiology · 75d
Cleared Aug 09, 1991
LATERAL SPINE DETERMAINATIONS DPX/DPX-L/DPX-ALPHA
K905291
Lunar
Radiology · 256d
Cleared Jun 10, 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753
Hologic, Inc.
Radiology · 168d
Cleared May 15, 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691
Hologic, Inc.
Radiology · 147d
Cleared Apr 29, 1991
NORLAND XR26 WHOLE BODY OPTION
K901804
Norland Corp.
Radiology · 374d
Cleared Dec 05, 1990
DPX-L AND DPX-ALPHA, MODIFICATION
K904980
Lunar
Radiology · 33d
Cleared Nov 23, 1990
NORLAND XR26 LATERAL SPINE OPTION
K902959
Norland Corp.
Radiology · 141d
Cleared Aug 30, 1990
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795
Hologic, Inc.
Radiology · 406d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415
K901832
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER SOURCES
K901848
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)
K901854
Amersham Corp.
Radiology · 76d
Cleared Jul 09, 1990
GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)
K901857
Amersham Corp.
Radiology · 76d
Cleared Apr 10, 1990
MODIFIED DPX BONE DENSITOMETER
K890121
Lunar
Radiology · 454d