Medical Device Manufacturer · US , Waukesha , WI

Ge Healthcare - FDA 510(k) Cleared Devices

168 submissions · 168 cleared · Since 2004
168
Total
168
Cleared
0
Denied
168 devices
101-125 of 168
Cleared Jul 26, 2011
LOGIQ S8
K111582 · IYN
Radiology · 50d
Cleared Jul 22, 2011
LOGIQ E9
K110943 · IYN
Radiology · 109d
Cleared Jul 19, 2011
ENTROPY EASYFIT SENSOR
K103129 · GWQ
Neurology · 270d
Cleared Jun 03, 2011
DISCOVERY NM 630
K111445 · KPS
Radiology · 10d
Cleared May 05, 2011
CENTRICITY PACS
K110875 · LLZ
Radiology · 36d
Cleared Apr 26, 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834 · LLZ
Radiology · 32d
Cleared Mar 09, 2011
VOLUSON S6, VOLUSON S8
K103649 · IYN
Radiology · 84d
Cleared Mar 07, 2011
GEM OPTION FOR 1.5 MRI SYSTEMS
K103335 · MOS
Radiology · 112d
Cleared Mar 04, 2011
VIEWPOINT 6
K103458 · LLZ
Radiology · 101d
Cleared Feb 08, 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/...
K101236 · IYN
Radiology · 281d
Cleared Oct 07, 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166 · LLZ
Radiology · 164d
Cleared Oct 05, 2010
GE LOGIQ P6/P6 PRO
K101874 · IYN
Radiology · 95d
Cleared Aug 31, 2010
GE LOGIQ P5 MODEL H44662LD
K101878 · IYN
Radiology · 56d
Cleared Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271 · IYN
Radiology · 112d
Cleared Aug 25, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ,...
K092004 · OWB
Radiology · 54d
Cleared Jun 29, 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA...
K091658 · OWB
Radiology · 20d
Cleared Nov 28, 2008
GE ENTROPY SENSOR
K082540 · GXY
Neurology · 87d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Radiology · 56d
Cleared May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889 · DSI
Cardiovascular · 315d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Radiology · 21d
Cleared Mar 27, 2008
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES
K061907 · OLW
Neurology · 631d
Cleared Dec 21, 2007
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · GXY
Neurology · 477d
Cleared Dec 20, 2007
MODEL 250CX SERIES MATERNAL/FETAL MONITOR
K072976 · HGM
Obstetrics & Gynecology · 56d
Cleared Nov 20, 2007
INTEGRADWEB PACS SYSTEM
K072986 · LLZ
Radiology · 28d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · FMZ
General Hospital · 81d

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