KGI · Class II · 21 CFR 892.1170

FDA Product Code KGI: Densitometer, Bone

Leading manufacturers include Hologic, Inc., Amersham Corp. and GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC.

147
Total
147
Cleared
155d
Avg days
1979
Since
147 devices
25–48 of 147
Cleared Nov 13, 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K983028
Hologic, Inc.
Radiology · 74d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787
Hologic, Inc.
Radiology · 400d
Cleared Nov 22, 1996
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363
Hologic, Inc.
Radiology · 87d
Cleared Aug 30, 1995
BONE MINERAL DENSITOMETER
K941362
Hologic, Inc.
Radiology · 527d
Cleared Jan 20, 1995
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505
Hologic, Inc.
Radiology · 184d
Cleared Jul 23, 1993
DTX-100
K926300
Hologic, Inc.
Radiology · 221d
Cleared Nov 01, 1991
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321
Hologic, Inc.
Radiology · 99d
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 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 Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999
Hologic, Inc.
Radiology · 297d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280
Hologic, Inc.
Radiology · 57d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360
Hologic, Inc.
Radiology · 49d
Cleared Oct 20, 1987
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446
Hologic, Inc.
Radiology · 190d
Cleared Oct 08, 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553
Hologic, Inc.
Radiology · 169d
Cleared Mar 09, 1987
BONE MINERAL DENSITOMETRY OPTION B7918AA
K863618
General Electric Co.
Radiology · 174d
Cleared Feb 02, 1987
OSTEOPAK BMD (BONE MINERAL DENSITOMETER)
K861515
Siemens Gammasonics, Inc.
Radiology · 285d