FDA 510(k) Applications Submitted by GE HEALTHCARE

FDA 510(k) Number Submission Date Device Name Applicant
K071175 04/27/2007 OHMEDA MEDICAL GIRAFFE OMNIBED GE HEALTHCARE
K072976 10/25/2007 MODEL 250CX SERIES MATERNAL/FETAL MONITOR GE HEALTHCARE
K091658 06/09/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 GE HEALTHCARE
K092004 07/02/2009 GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ GE HEALTHCARE
K061741 06/20/2006 MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM GE HEALTHCARE
K081105 04/18/2008 GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) GE HEALTHCARE
K153003 10/13/2015 SIGNA Pioneer GE HEALTHCARE
K152567 09/09/2015 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System GE Healthcare
K183116 11/09/2018 Unity Network ID GE Healthcare
K120221 01/25/2012 GE ECHOPAC GE HEALTHCARE
K160182 01/27/2016 LOGIQ S7 Expert GE Healthcare
K180374 02/12/2018 Voluson S8/ Voluson S10/ Voluson S10 Expert GE Healthcare
K170445 02/14/2017 LOGIQ S8 GE Healthcare
K180535 02/28/2018 Voluson P6 and Voluson P8 GE Healthcare
K120741 03/12/2012 VOLUSON S6, VOLUSON S8 GE HEALTHCARE
K180641 03/12/2018 Invenia ABUS Viewer GE Healthcare
K110943 04/04/2011 LOGIQ E9 GE HEALTHCARE
K161047 04/13/2016 LOGIQ P9 and LOGIQ P7 GE Healthcare
K131118 04/22/2013 4D VIEW GE HEALTHCARE
K141067 04/24/2014 VIVID T8/VIVID T8 PRO GE HEALTHCARE
K101166 04/26/2010 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ GE HEALTHCARE
K101236 05/03/2010 VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM GE HEALTHCARE
K131267 05/03/2013 VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 GE HEALTHCARE
K141261 05/15/2014 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE
K131527 05/28/2013 LOGIQ S8 GE HEALTHCARE
K111582 06/06/2011 LOGIQ S8 GE HEALTHCARE
K141639 06/19/2014 VOLUSON S6, VOLUSON S8 GE HEALTHCARE
K141675 06/25/2014 VOLUSON P6, VOLUSON P8 GE HEALTHCARE
K131937 06/27/2013 VOLUSON I/E GE HEALTHCARE
K141768 07/01/2014 LOGIQ V5/LOGIQ V3 GE HEALTHCARE
K101874 07/02/2010 GE LOGIQ P6/P6 PRO GE HEALTHCARE
K181783 07/03/2018 LOGIQ P9; LOGIQ P7 GE Healthcare
K101878 07/06/2010 GE LOGIQ P5 MODEL H44662LD GE HEALTHCARE
K122114 07/17/2012 LOGIQ S7 EXPERT, LOGIQ S7 PRO GE HEALTHCARE
K112122 07/25/2011 VENUE 40 GE HEALTHCARE
K181985 07/25/2018 Voluson E6, Voluson E8, Voluson E10 GE Healthcare
K122327 08/01/2012 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE
K112213 08/02/2011 VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE
K172342 08/02/2017 Voluson E6, Voluson E8, Voluson E10 GE Healthcare
K152195 08/05/2015 LOGIQ S8 GE Healthcare
K122387 08/06/2012 VOLUSON P6, VOLUSON P8 GE HEALTHCARE
K142160 08/06/2014 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE
K162269 08/12/2016 Voluson E6, Voluson E8, Voluson E10 GE Healthcare
K112371 08/17/2011 LOGIQ P3 GE HEALTHCARE
K122515 08/17/2012 C2-9-D ULTRASOUND TRANSDUCER GE HEALTHCARE
K132913 09/17/2013 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE
K122921 09/24/2012 C1-6-D ULTRASOUND TRANSDUCER GE HEALTHCARE
K133034 09/26/2013 LOGIQ F SERIES GE HEALTHCARE
K133431 11/08/2013 VENUE 50 GE HEALTHCARE
K173555 11/17/2017 LOGIQ E10 GE Healthcare
K133533 11/18/2013 LOGIQ E GE HEALTHCARE
K123564 11/20/2012 LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE
K143452 12/02/2014 LOGIQ P9, LOGIQ P7 GE HEALTHCARE
K103649 12/15/2010 VOLUSON S6, VOLUSON S8 GE HEALTHCARE
K113690 12/15/2011 GE LOGIQ I, LOGIQ E AND VIVID E GE HEALTHCARE
K113758 12/21/2011 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE
K163596 12/21/2016 LOGIQ P9 and LOGIQ P7 GE HEALTHCARE
K163302 11/22/2016 Senographe Pristina GE Healthcare
K121200 04/19/2012 FLIGHTPLAN FOR LIVER GE HEALTHCARE
K111200 04/29/2011 MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM GE HEALTHCARE
K113034 10/11/2011 GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM GE HEALTHCARE
K150420 02/18/2015 Centricity Universal Viewer GE HEALTHCARE
K110875 03/30/2011 CENTRICITY PACS GE HEALTHCARE
K123174 10/10/2012 CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE HEALTHCARE
K062393 08/16/2006 GE VANTAGE PET NEURO SOFTWARE GE HEALTHCARE
K160933 04/04/2016 Discovery NM 750b Bopsy GE Healthcare
K153355 11/20/2015 Xeleris 4.0 Processing and Review Workstation GE HEALTHCARE
K121019 04/04/2012 OPTIMA NM/CT 640 GE HEALTHCARE
K113350 11/14/2011 BRIVO NM 615 GE HEALTHCARE
K111209 04/29/2011 INTEGRATED INNOVA - S5I SYSTEM OPTION GE HEALTHCARE
K153402 11/24/2015 Discovery NM/CT 670 CZT GE HEALTHCARE
K173816 12/15/2017 NM/CT 850, NM/CT 860 GE Healthcare
K160621 03/04/2016 SIGNAPioneer GE HEALTHCARE
K161567 06/07/2016 SIGNA Voyager GE HEALTHCARE
K162268 08/12/2016 Senographe Pristina GE HEALTHCARE
K173576 11/20/2017 Pristina Serena GE Healthcare
K110834 03/25/2011 AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION GE HEALTHCARE
K072986 10/23/2007 INTEGRADWEB PACS SYSTEM GE HEALTHCARE
K070421 02/13/2007 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 GE HEALTHCARE
K050837 04/01/2005 REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE GE HEALTHCARE
K071020 04/10/2007 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE GE HEALTHCARE
K061185 04/28/2006 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE GE HEALTHCARE
K051217 05/12/2005 DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) GE HEALTHCARE
K061918 07/06/2006 FOLEY CATHETERS WITH TEMPERATURE PROBE GE HEALTHCARE
K051883 07/12/2005 DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. GE HEALTHCARE
K061994 07/14/2006 WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE GE HEALTHCARE
K052145 08/08/2005 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE HEALTHCARE
K062324 08/09/2006 MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN GE HEALTHCARE
K062576 08/31/2006 DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES GE HEALTHCARE
K062580 08/31/2006 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) GE HEALTHCARE
K052582 09/20/2005 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES GE HEALTHCARE
K052755 09/30/2005 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE HEALTHCARE
K052756 09/30/2005 DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM GE HEALTHCARE
K103129 10/22/2010 ENTROPY EASYFIT SENSOR GE HEALTHCARE
K052975 10/24/2005 DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE GE HEALTHCARE
K052976 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES GE HEALTHCARE
K052977 10/24/2005 DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES GE HEALTHCARE
K052972 10/24/2005 DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE HEALTHCARE
K053121 11/07/2005 TRAM MODULE GE HEALTHCARE
K050835 04/01/2005 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE
K051092 04/28/2005 DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC GE HEALTHCARE
K051400 05/31/2005 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS GE HEALTHCARE
K051635 06/20/2005 DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES GE HEALTHCARE
K051634 06/20/2005 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE HEALTHCARE
K061907 07/05/2006 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE HEALTHCARE
K071889 07/09/2007 DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE GE HEALTHCARE
K061942 07/10/2006 TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237 GE HEALTHCARE
K051873 07/11/2005 DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES GE HEALTHCARE
K052167 08/09/2005 DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES GE HEALTHCARE
K082540 09/02/2008 GE ENTROPY SENSOR GE HEALTHCARE
K052880 10/12/2005 DATEX-OHMEDA S/5 INTERFACE MODULE E-INT GE HEALTHCARE
K051967 07/20/2005 REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS GE HEALTHCARE
K052839 10/07/2005 CT PERFUSION 4 GE HEALTHCARE
K060779 03/22/2006 ADVANCE VESSEL ANALYSIS II GE HEALTHCARE
K061370 05/17/2006 CARDIQ FUSION GE HEALTHCARE
K041543 06/08/2004 GE DISCOVERY ST GE HEALTHCARE
K061587 06/08/2006 FULLCARD ANALYSIS GE HEALTHCARE
K061625 06/12/2006 AUTOBONE2 GE HEALTHCARE
K052345 08/26/2005 ADVANTAGE SIM MD GE HEALTHCARE
K052412 09/02/2005 INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE HEALTHCARE
K052995 10/25/2005 ADVANTAGE WORKSTATION 4.3. GE HEALTHCARE
K063324 11/03/2006 PET VCAR GE HEALTHCARE
K043262 11/24/2004 GE SIGNA EXCITE MR SURGICAL OPTION GE HEALTHCARE
K052855 10/11/2005 STARSPEED SERIES CT SCANNER SYSTEMS GE HEALTHCARE
K122457 08/13/2012 GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE HEALTHCARE
K081091 04/16/2008 PRECISION 500D R&F X-RAY SYSTEM GE HEALTHCARE
K103335 11/15/2010 GEM OPTION FOR 1.5 MRI SYSTEMS GE HEALTHCARE
K181403 05/29/2018 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare
K160937 04/04/2016 Senolris GE Healthcare
K172404 08/09/2017 SenoBright HD GE Healthcare
K143361 11/24/2014 Mammo Workstation GE HEALTHCARE
K131977 06/28/2013 CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE HEALTHCARE
K092271 07/28/2009 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE HEALTHCARE
K182951 10/23/2018 Pristina Serena 3D GE Healthcare
K103458 11/23/2010 VIEWPOINT 6 GE HEALTHCARE
K130069 01/11/2013 INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 GE HEALTHCARE
K182419 09/05/2018 Centricity Universal Viewer GE Healthcare
K170199 01/23/2017 Unity Network ID GE Healthcare
K162012 07/21/2016 CARESCAPE Central Station V2 GE HEALTHCARE
K142840 09/30/2014 Unity Network ID GE HEALTHCARE
K111445 05/24/2011 DISCOVERY NM 630 GE HEALTHCARE
K160162 01/27/2016 Voluson P6, Voluson P8 GE HEALTHCARE
K160184 01/27/2016 Voluson S6, Voluson S8, Voluson S10 GE HEALTHCARE
K142472 09/03/2014 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems GE Healthcare
K182590 09/20/2018 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA GE Healthcare


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