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
25–48 of 148
Cleared Oct 16, 2008
OSDX HIP BMD SYSTEM
K082402
Imaging Therapeutics, Inc.
Radiology · 57d
Cleared Sep 26, 2008
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
K082317
General Electric Co.
Radiology · 44d
Cleared Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION
K080711
Hologic, Inc.
Radiology · 173d
Cleared Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
K072847
Hologic, Inc.
Radiology · 176d
Cleared Sep 14, 2007
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K072439
Ge Medical Systems Ultrasound and Primary Care Dia
Radiology · 15d
Cleared Jun 27, 2007
GE LUNAR BODY COMPOSITION SOFTWARE
K071570
Ge Medical Systems Lunar
Radiology · 19d
Cleared Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
K061561
Hologic, Inc.
Radiology · 53d
Cleared Apr 24, 2006
IVA (MXA II SOFTWARE OPTION)
K060111
Hologic, Inc.
Radiology · 97d
Cleared Oct 20, 2005
LUNAR IDXA
K052581
Ge Medical Systems Ultrasound and Primary Care Dia
Radiology · 30d
Cleared Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
K042480
Hologic, Inc.
Radiology · 46d
Cleared Aug 11, 2004
PEDIATRIC REFERENCE DATABASE
K041266
Hologic, Inc.
Radiology · 91d
Cleared May 05, 2004
DXL CALSCAN
K033550
Demetech AB
Radiology · 175d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224
Hologic, Inc.
Radiology · 30d
Cleared Jul 30, 2003
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
K031991
Image Analysis, Inc.
Radiology · 33d
Cleared Jul 25, 2003
DPX SERIES BRAVO DUO BONE DENSITOMETER
K030962
Ge Lunar Corp.
Radiology · 120d
Cleared Jun 20, 2003
CTXA HIP EXTENDED REFERENCE DATA
K030330
Mindways Software, Inc.
Radiology · 140d
Cleared Dec 20, 2002
DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE
K023554
Ge Lunar Corp.
Radiology · 58d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398
Hologic, Inc.
Radiology · 30d
Cleared Jun 07, 2002
SECTRA OSTEOPOROSIS PACKAGE
K021527
Sectra-Imtec AB
Radiology · 28d
Cleared May 21, 2002
DEXACARE G4
K021331
Osteometer Meditech, Inc.
Radiology · 25d
Cleared Dec 04, 2001
CTXA HIP
K002113
Mindways Software, Inc.
Radiology · 545d
Cleared Aug 03, 2001
ADVANCED HIP ASSESSMENT SOFTWARE
K011917
Ge Lunar Corp.
Radiology · 44d
Cleared Dec 15, 2000
X-POSURE SYSTEM VERSION 2 MAMMO
K003656
Pronosco A/S
Radiology · 18d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500
Pronosco A/S
Radiology · 70d