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
123 devices
101-123 of 123
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 Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091 · JAA
Radiology · 56d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Radiology · 21d
Cleared Nov 20, 2007
INTEGRADWEB PACS SYSTEM
K072986 · LLZ
Radiology · 28d
Cleared Mar 23, 2007
PET VCAR
K063324 · JAK
Radiology · 140d
Cleared Sep 01, 2006
GE VANTAGE PET NEURO SOFTWARE
K062393 · KPS
Radiology · 16d
Cleared Jun 26, 2006
AUTOBONE2
K061625 · JAK
Radiology · 14d
Cleared Jun 23, 2006
FULLCARD ANALYSIS
K061587 · KPS
Radiology · 15d
Cleared May 30, 2006
CARDIQ FUSION
K061370 · JAK
Radiology · 13d
Cleared Apr 05, 2006
ADVANCE VESSEL ANALYSIS II
K060779 · JAK
Radiology · 14d
Cleared Mar 10, 2006
CT PERFUSION 4
K052839 · JAK
Radiology · 154d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Radiology · 14d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855 · JAK
Radiology · 17d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Radiology · 14d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Radiology · 19d
Cleared Aug 09, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · KPR
Radiology · 20d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Radiology · 49d
Cleared Jun 22, 2004
GE DISCOVERY ST
K041543 · KPS
Radiology · 14d

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