FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS

FDA 510(k) Number Submission Date Device Name Applicant
K020929 03/22/2002 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 GE MEDICAL SYSTEMS
K936180 12/27/1993 TC+ SYSTEM (TILTING C-ARM SYSTEM) GE MEDICAL SYSTEMS
K960527 02/06/1996 LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM GE MEDICAL SYSTEMS
K000571 02/22/2000 GE LOGIQ 700 GE MEDICAL SYSTEMS
K001016 03/29/2000 GE LOGIQ 700 GE MEDICAL SYSTEMS
K951723 04/14/1995 GE B510 TRANSDUCER GE MEDICAL SYSTEMS
K011188 04/18/2001 GE LOGIQ 9, MODEL 2188900-X GE MEDICAL SYSTEMS
K051449 06/02/2005 GE VIVID 7 WITH OR WITHOUT SUFFIX GE MEDICAL SYSTEMS
K955185 11/13/1995 GE ADVANTAGE DICOM CR REPROCESSING STATION GE MEDICAL SYSTEMS
K014097 12/12/2001 GE LOGIQ 5 GE MEDICAL SYSTEMS
K050559 03/03/2005 GE DISCOVERY VCT SYSTEM GE MEDICAL SYSTEMS
K960700 02/20/1996 LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K970901 03/11/1997 GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K041220 05/10/2004 GE DISCOVERY ST SYSTEM GE MEDICAL SYSTEMS
K964617 10/28/1996 GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K964886 12/06/1996 GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K052434 09/06/2005 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS
K012775 08/20/2001 GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER GE MEDICAL SYSTEMS
K013481 10/19/2001 DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION GE MEDICAL SYSTEMS
K030420 02/10/2003 LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM GE MEDICAL SYSTEMS
K901730 04/16/1990 GE SIGNA ADVANTAGE GE MEDICAL SYSTEMS
K902428 05/31/1990 INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS GE MEDICAL SYSTEMS
K895794 09/28/1989 GE MR MAX SYSTEM GE MEDICAL SYSTEMS
K896353 11/06/1989 GE TARGET SERIES 2 GE MEDICAL SYSTEMS
K915138 11/13/1991 GE SONOCHROME GE MEDICAL SYSTEMS
K031927 06/23/2003 GE DELTA SOFTWARE OPTION FOR MRI GE MEDICAL SYSTEMS
K921192 03/12/1992 CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM GE MEDICAL SYSTEMS
K941191 03/14/1994 REAL TIME STEREOTIX GE MEDICAL SYSTEMS
K911387 03/29/1991 CT SYTEC 4000 GE MEDICAL SYSTEMS
K981190 04/02/1998 HIGH IMPEDANCE CARDIAC GATING CABLE GE MEDICAL SYSTEMS
K981217 04/03/1998 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION GE MEDICAL SYSTEMS
K031230 04/18/2003 GE PROPELLER IMAGING OPTION FOR MRI GE MEDICAL SYSTEMS
K892943 04/21/1989 MULTI PULSE POWER UNIT GENERATOR GE MEDICAL SYSTEMS
K941946 04/21/1994 LCA ANGIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS
K893509 05/05/1989 GE SIGNA ADVANTAGE GE MEDICAL SYSTEMS
K031637 05/27/2003 INNOVA 3100 GE MEDICAL SYSTEMS
K894142 06/13/1989 ULTRANET-S COLLIMATOR GE MEDICAL SYSTEMS
K932957 06/17/1993 QUANTEM (TM) GE MEDICAL SYSTEMS
K894269 06/22/1989 CT HILIGHT ADVANTAGE GE MEDICAL SYSTEMS
K032045 07/02/2003 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS
K022669 08/12/2002 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS
K012875 08/27/2001 SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K012970 09/04/2001 GE SIGNA ASSET IMAGING OPTION GE MEDICAL SYSTEMS
K023442 10/15/2002 EXTRA LARGE BODY COIL GE MEDICAL SYSTEMS
K904971 11/05/1990 CT HILIGHT ADVANTAGE II GE MEDICAL SYSTEMS
K942120 05/03/1994 ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION GE MEDICAL SYSTEMS
K923025 06/23/1992 SIGNA BREAST COIL AND ARRAY ACCESSORY GE MEDICAL SYSTEMS
K944112 08/23/1994 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE MEDICAL SYSTEMS
K980114 01/13/1998 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K960265 01/18/1996 ADVANTAGE WINDOWS WITH FUNCTOOL OPTION GE MEDICAL SYSTEMS
K930265 01/19/1993 HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT GE MEDICAL SYSTEMS
K950317 01/26/1995 ADVANTX 1824 SPOTFILM DEVICE GE MEDICAL SYSTEMS
K040172 01/26/2004 MODIFICATION TO GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS
K000315 02/01/2000 VENTRICULAR ANALYSIS TOOLKIT OPTION GE MEDICAL SYSTEMS
K940606 02/10/1994 HISPEED ADVANTAGE II GE MEDICAL SYSTEMS
K930768 02/16/1993 ORION DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K970606 02/18/1997 COMPUTED TOMOGRAPHY X-RAY SYSTEM GE MEDICAL SYSTEMS
K931049 03/01/1993 ADVANTX SYSTEM GE MEDICAL SYSTEMS
K950973 03/02/1995 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K910902 03/05/1991 VMX MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS
K910967 03/06/1991 NEUROCAM GE MEDICAL SYSTEMS
K020796 03/12/2002 CARD IQ ANALYSIS II GE MEDICAL SYSTEMS
K951144 03/13/1995 PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS GE MEDICAL SYSTEMS
K000802 03/13/2000 SPIRAL IMAGING OPTION GE MEDICAL SYSTEMS
K961055 03/18/1996 CT PROSPEED CT/I GE MEDICAL SYSTEMS
K021016 03/29/2002 AMX-4 PLUS MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS
K921777 04/14/1992 CARDIAC FIRST PASS ANALYSIS GE MEDICAL SYSTEMS
K031261 04/21/2003 CARD EP GE MEDICAL SYSTEMS
K031396 05/02/2003 ADVANTAGE WORKSTATION PASTING 1.1 GE MEDICAL SYSTEMS
K911959 05/03/1991 SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF GE MEDICAL SYSTEMS
K971667 05/06/1997 CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS
K971668 05/06/1997 SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS GE MEDICAL SYSTEMS
K011624 05/25/2001 EXPEDIO 500D R&F X-RAY SYSTEM GE MEDICAL SYSTEMS
K962061 05/28/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K912539 06/10/1991 SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K992066 06/18/1999 REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM GE MEDICAL SYSTEMS
K982196 06/22/1998 DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS
K051673 06/23/2005 XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS
K923077 06/25/1992 ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION GE MEDICAL SYSTEMS
K912881 07/01/1991 GE MR MAX GE MEDICAL SYSTEMS
K933202 07/01/1993 VENUS DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS
K923309 07/07/1992 ARGUS PET SYSTEM GE MEDICAL SYSTEMS
K943355 07/12/1994 GEMNET GE MEDICAL SYSTEMS
K953250 07/12/1995 SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE GE MEDICAL SYSTEMS
K933447 07/13/1993 STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM GE MEDICAL SYSTEMS
K012200 07/13/2001 1.5T INFINITY TWINSPEED MR SYSTEM GE MEDICAL SYSTEMS
K022397 07/23/2002 SIGNA 3.0T MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K953595 07/31/1995 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE MEDICAL SYSTEMS
K913475 08/05/1991 MAGNETIC RESONANCE DIAGNOSTIC DEVICE GE MEDICAL SYSTEMS
K903608 08/09/1990 V-LINK GE MEDICAL SYSTEMS
K963179 08/14/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K973039 08/14/1997 LEGACY/LEGACY-D TABLE GE MEDICAL SYSTEMS
K944013 08/16/1994 CT PROSPEED FAMILY GE MEDICAL SYSTEMS
K953832 08/16/1995 SOLARIX FV GE MEDICAL SYSTEMS
K002611 08/22/2000 SIGNA MFO/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K012836 08/23/2001 MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM GE MEDICAL SYSTEMS
K982955 08/24/1998 SILHOUETTE VR GE MEDICAL SYSTEMS
K973168 08/25/1997 SMARTVIEW OPTIONS FOR HISPEED CT/I GE MEDICAL SYSTEMS
K982972 08/25/1998 SIGNA PROFILE SMALL HEAD COIL GE MEDICAL SYSTEMS
K924310 08/26/1992 PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC GE MEDICAL SYSTEMS
K963345 08/26/1996 ADVANTAGE WINDOWS TISSUE VOLUME OPTION GE MEDICAL SYSTEMS
K963429 08/30/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K924498 09/04/1992 MAXXUS GE MEDICAL SYSTEMS
K022919 09/04/2002 SMART BREATH RESPIRATORY COMPENSATION OPTION GE MEDICAL SYSTEMS
K934367 09/07/1993 PC-MINI GE MEDICAL SYSTEMS
K983139 09/08/1998 SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL GE MEDICAL SYSTEMS
K934499 09/14/1993 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE MEDICAL SYSTEMS
K983256 09/16/1998 ADVANTAGE WINDOWS (AW) FUSION GE MEDICAL SYSTEMS
K914267 09/23/1991 GE 4096 PLUS & GE 2048 GE MEDICAL SYSTEMS
K002978 09/25/2000 LIGTHSPEED 3.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS
K002997 09/26/2000 FIESTA IMAGING OPTION GE MEDICAL SYSTEMS
K963896 09/27/1996 MOBILE CT PROSPEED FAMILY GE MEDICAL SYSTEMS
K042694 09/30/2004 ADVANCED LUNG ANALYSIS II GE MEDICAL SYSTEMS
K964012 10/07/1996 GENIE PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS
K023332 10/07/2002 LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW GE MEDICAL SYSTEMS
K954666 10/10/1995 MPH50, MPH65, AND MPH80 GE MEDICAL SYSTEMS
K944967 10/11/1994 TOMO-LINK GE MEDICAL SYSTEMS
K944979 10/11/1994 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE MEDICAL SYSTEMS
K954874 10/24/1995 SPECTEF PROTOCOL GE MEDICAL SYSTEMS
K013561 10/26/2001 LIGHTSPEED 4.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS
K053009 10/26/2005 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS
K964370 11/01/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K945375 11/02/1994 ADVANTX LCA GE MEDICAL SYSTEMS
K003408 11/02/2000 CT CORD IQ OPTION 1.0 GE MEDICAL SYSTEMS
K013636 11/05/2001 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE MEDICAL SYSTEMS
K945652 11/17/1994 ATTENUATION CORRECTION GE MEDICAL SYSTEMS
K974367 11/20/1997 ADVANTX LCN, ADVANTX LCLP GE MEDICAL SYSTEMS
K984167 11/20/1998 SAGE 7 GE MEDICAL SYSTEMS
K003575 11/20/2000 MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K945730 11/22/1994 SIGNA PROFILE GE MEDICAL SYSTEMS
K003613 11/22/2000 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL GE MEDICAL SYSTEMS
K964746 11/26/1996 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION GE MEDICAL SYSTEMS
K945842 11/30/1994 MOBILIX MOBILE X-RAY TABLE GE MEDICAL SYSTEMS
K023988 12/02/2002 GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS
K936001 12/15/1993 PATLAK & FDG AUTORADIOGRAPHIC GE MEDICAL SYSTEMS
K974715 12/17/1997 ADVANTAGE 3D XR GE MEDICAL SYSTEMS
K905653 12/18/1990 ADVANTX AFM ANGIO SYSTEM S1808 GE MEDICAL SYSTEMS
K926258 12/18/1992 DLX GE MEDICAL SYSTEMS
K003946 12/21/2000 SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE MEDICAL SYSTEMS
K003947 12/21/2000 FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE MEDICAL SYSTEMS
K903319 07/25/1990 MAGNETIC RESONANCE DIAGNOSTIC DEVICE GE MEDICAL SYSTEMS
K940300 01/24/1994 MAGELLAN GE MEDICAL SYSTEMS
K980322 01/27/1998 ACCENT 16, ACCENT 22 GE MEDICAL SYSTEMS
K960575 02/12/1996 ADVANTX LCV+ GE MEDICAL SYSTEMS
K960613 02/13/1996 GE ADVANTAGE WINDOWS REVIEW WORKSTATION GE MEDICAL SYSTEMS
K942604 06/01/1994 SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K962738 07/15/1996 MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS GE MEDICAL SYSTEMS
K943652 07/28/1994 VASCULAR MP X-RAY GENERATOR GE MEDICAL SYSTEMS
K964969 12/12/1996 SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) GE MEDICAL SYSTEMS
K965010 12/16/1996 TARGET 2 VERSION 1.1 GE MEDICAL SYSTEMS
K972990 08/12/1997 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K960139 01/16/1996 G.E. STERILE ANGIOGRAPHIC TRAY GE MEDICAL SYSTEMS
K960141 01/16/1996 G.E. STERILE, STANDARD BIOPSY TRAY GE MEDICAL SYSTEMS
K960143 01/16/1996 G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY GE MEDICAL SYSTEMS
K960144 01/16/1996 G.E. STERILE CT BIOPSY TRAY GE MEDICAL SYSTEMS
K960146 01/16/1996 G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY GE MEDICAL SYSTEMS
K960201 01/16/1996 G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY GE MEDICAL SYSTEMS
K960202 01/16/1996 G.E. STERILE PUNCTURE TRAY GE MEDICAL SYSTEMS
K960203 01/16/1996 G.E. STERILE AMNIOCENTESIS TRAY GE MEDICAL SYSTEMS
K960204 01/16/1996 G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY GE MEDICAL SYSTEMS
K962035 05/24/1996 GE STERILE ARTHROGRAM TRAY GE MEDICAL SYSTEMS
K023557 10/23/2002 CENTRICITY PACS PLUS GE MEDICAL SYSTEMS
K020483 02/13/2002 ADVANTAGE WORKSTATION 4.1 GE MEDICAL SYSTEMS
K073138 11/07/2007 CARDIQ EXPRESS VERSION 2.0 GE MEDICAL SYSTEMS
K013422 10/15/2001 CARDIQ FUNCTION GE MEDICAL SYSTEMS
K103411 11/22/2010 IDEAL IQ SOFTWARE OPTION GE MEDICAL SYSTEMS
K173341 10/24/2017 Vivid E80, Vivid E90, Vivid E95 GE Medical Systems


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