Medical Device Manufacturer · US , Waltham , MA

Hologic, Inc. - FDA 510(k) Cleared Devices

116 submissions · 112 cleared · Since 1987
116
Total
112
Cleared
2
Denied
116 devices
101-116 of 116
Cleared Jan 12, 1998
FS IV MINI C-ARM SYSTEM
K974058 · JAA
Radiology · 77d
Cleared Jun 13, 1997
BODY COMPOSITION SOFTWARE OPTION FOR QDR X-RAY BONE DENSITOMETERS
K961787 · KGI
Radiology · 400d
Cleared Nov 22, 1996
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363 · KGI
Radiology · 87d
Cleared Aug 30, 1995
BONE MINERAL DENSITOMETER
K941362 · KGI
Radiology · 527d
Cleared Jan 20, 1995
HOLOGIC QDR-3000 X-RAY BONE DENSITOMETER
K943505 · KGI
Radiology · 184d
Cleared Jul 23, 1993
DTX-100
K926300 · KGI
Radiology · 221d
Cleared Nov 01, 1991
HOLOGIC QDR-2000 X-RAY BONE DENSITOMETER
K913321 · KGI
Radiology · 99d
Cleared Oct 30, 1991
HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
K913757 · KPR
Radiology · 70d
Cleared Jun 10, 1991
QDR-1000 AND QDR-1000/W X-RAY BONE DENSITOMETER
K905753 · KGI
Radiology · 168d
Cleared May 15, 1991
QDR-1000 AND WITH X-RAY BONE DENSITOMETER
K905691 · KGI
Radiology · 147d
Cleared Aug 30, 1990
HOLOGIC QDR-1000/W X-RAY BONE DENSITOMETER
K894795 · KGI
Radiology · 406d
Cleared Dec 21, 1989
MODIFIED QDR-1000 X-RAY BONE DENSITOMETER
K890999 · KGI
Radiology · 297d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · KGI
Radiology · 57d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · KGI
Radiology · 49d
Cleared Oct 20, 1987
HOLOGIC MODELS BLK-1, DPA/QDR-1 & QCT-1
K871446 · KGI
Radiology · 190d
Cleared Oct 08, 1987
X-CALIBER MODEL 1000 BONE MINERAL ANALYZER
K871553 · KGI
Radiology · 169d

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