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
49–72 of 148
Cleared Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER
K002711
Hologic, Inc.
Radiology · 28d
Cleared Jul 10, 2000
PEDIATRIC REFERENCE DATA
K001812
Lunar Corp.
Radiology · 25d
Cleared Jul 06, 2000
LUNAR REPORT GENERATOR II
K001756
Lunar Corp.
Radiology · 27d
Cleared Jun 20, 2000
MULTI-RACIAL REFERENCE POPULATION FOR PDEXA AND DISCOVERY
K993176
Norland Medical Systems, Inc.
Radiology · 272d
Cleared May 26, 2000
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K001429
Schick Technologies, Inc.
Radiology · 21d
Cleared May 16, 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337
Norland Medical Systems, Inc.
Radiology · 224d
Cleared May 12, 2000
METRISCAN BONE DENSITY SYSTEM
K000162
Alara, Inc.
Radiology · 114d
Cleared Apr 14, 2000
PRODIGY LATERAL VIEW SOFTWARE
K000826
Lunar Corp.
Radiology · 31d
Cleared Nov 22, 1999
XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46
K992125
Norland Medical Systems, Inc.
Radiology · 152d
Cleared Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992775
Hologic, Inc.
Radiology · 44d
Cleared Sep 03, 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246
Image Analysis, Inc.
Radiology · 59d
Cleared Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W
K992677
Hologic, Inc.
Radiology · 24d
Cleared May 19, 1999
OSTEOGRAM BONE DENSITOMETER
K984285
Compumed, Inc.
Radiology · 169d
Cleared Feb 18, 1999
PRONOSCO X-POSURE SYSTEM
K984178
Torsana Osteoporosis Diagnostics A/S
Radiology · 90d
Cleared Dec 08, 1998
PRODIGY TOTAL BODY SOFTWARE
K983564
Lunar Corp.
Radiology · 56d
Cleared Dec 08, 1998
ORCA-DX BONE DENSITOMETER
K983724
Lunar Corp.
Radiology · 47d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
K983262
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
K983269
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271
Lunar Corp.
Radiology · 62d
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 Oct 29, 1998
XCT 2000 L PQCT BONE DENSITOMETER
K983273
Medical Systems, Inc.
Radiology · 42d
Cleared Aug 18, 1998
DPX-RX BONE DENSITOMETER
K982267
Lunar Corp.
Radiology · 50d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K980289
Norland Corp.
Radiology · 137d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
K980569
Norland Corp.
Radiology · 119d