Hologic, Inc. - FDA 510(k) Cleared Devices
116
Total
112
Cleared
2
Denied
116 devices
Cleared
Dec 02, 2010
SECRMARK BIOPSY SITE MARKING SYSTEM
General & Plastic Surgery
69d
Cleared
Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
Radiology
27d
Cleared
Aug 27, 2009
MAMMOSITE MULTI LUMEN
Radiology
21d
Cleared
Jul 02, 2009
MAMMOSITE II RADIATION THERAPY SYSTEM
Radiology
52d
Cleared
Jun 04, 2009
R2 DIGITALNOW HD(DIGITALNOW HD)
Radiology
27d
Cleared
Sep 12, 2008
QUANTRA
Radiology
15d
Cleared
Sep 02, 2008
1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER,...
Radiology
173d
Cleared
May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
Radiology
14d
Cleared
Mar 28, 2008
APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
Radiology
176d
Cleared
Dec 21, 2007
IMAGECHECKER CT CAD SOFTWARE SYSTEM
Radiology
25d
Cleared
Aug 18, 2006
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
Radiology
25d
Cleared
Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE...
Radiology
53d
Cleared
Apr 24, 2006
IVA (MXA II SOFTWARE OPTION)
Radiology
97d
Cleared
May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
Radiology
21d
Cleared
Oct 29, 2004
INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS
Radiology
46d
Cleared
Aug 11, 2004
PEDIATRIC REFERENCE DATABASE
Radiology
91d
Cleared
Aug 09, 2004
SECURVIEW DX SOFTCOPY WORKSTATION
Radiology
60d
Cleared
Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
Radiology
18d
Cleared
Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
Radiology
30d
Cleared
Oct 16, 2003
HOLOGIC DR IMAGEPRO
Radiology
59d
Cleared
Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
Radiology
30d
Cleared
Sep 28, 2000
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND...
Radiology
28d
Cleared
Oct 01, 1999
OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
Radiology
44d
Cleared
Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
Radiology
24d
Cleared
Nov 13, 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000,...
Radiology
74d
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