FDA 510(k) Applications Submitted by LARRY KROGER

FDA 510(k) Number Submission Date Device Name Applicant
K030495 02/19/2003 3.0T TORSO PHASED ARRAY COIL GE MEDICAL SYSTEMS, INC.
K030953 03/27/2003 GE 3.0T GENERAL PURPOSE FLEX COIL GE MEDICAL SYSTEMS, INC.
K981190 04/02/1998 HIGH IMPEDANCE CARDIAC GATING CABLE GE MEDICAL SYSTEMS
K981217 04/03/1998 PLATINUM READING, REVIEW & ANALYSIS WORKSTATION GE MEDICAL SYSTEMS
K061028 04/13/2006 PRECISION THUNIS 800+ GE MEDICAL SYSTEMS, LLC
K031209 04/17/2003 GE 1.5T 8 CHANNEL TORSO COIL GE MEDICAL SYSTEMS, INC.
K031230 04/18/2003 GE PROPELLER IMAGING OPTION FOR MRI GE MEDICAL SYSTEMS
K991629 05/11/1999 GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C GE MEDICAL SYSTEMS, INC.
K031637 05/27/2003 INNOVA 3100 GE MEDICAL SYSTEMS
K031871 06/17/2003 AUTOBONE GE MEDICAL SYSTEMS EUROPE
K032045 07/02/2003 8 CHANNEL CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS
K022310 07/17/2002 ADVANTAGE WINDOWS X-RAY/MR FUSION GE MEDICAL SYSTEMS, INC.
K012313 07/23/2001 CT COLONOGRAPHY/NAVIGATOR2 GE MEDICAL SYSTEMS, INC.
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
K052839 10/07/2005 CT PERFUSION 4 GE HEALTHCARE
K023442 10/15/2002 EXTRA LARGE BODY COIL GE MEDICAL SYSTEMS
K042844 10/15/2004 GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL GE MEDICAL SYSTEMS, INC.
K010042 01/05/2001 CT PERFUSION 2 GENERAL ELECTRIC CO.
K980114 01/13/1998 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K980169 01/16/1998 HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS GENERAL ELECTRIC CO.
K960265 01/18/1996 ADVANTAGE WINDOWS WITH FUNCTOOL OPTION GE MEDICAL SYSTEMS
K980176 01/20/1998 HISPEED QX/I CT SCANNER SYSTEM GENERAL ELECTRIC CO.
K040125 01/20/2004 SENOGRAPHIC STEREO GE MEDICAL SYSTEMS, INC.
K040444 01/20/2004 GE SIGNA 3.0T WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO.
K040172 01/26/2004 MODIFICATION TO GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS
K970303 01/27/1997 SATURNE MULTILEAF COLLIMATOR GENERAL ELECTRIC CO.
K000300 01/31/2000 LIGHTSPEED 2.0CT SCANNER SYSTEM GE MEDICAL SYSTEMS, INC.
K000315 02/01/2000 VENTRICULAR ANALYSIS TOOLKIT OPTION GE MEDICAL SYSTEMS
K060259 02/01/2006 DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121 GE MEDICAL SYSTEMS, LLC
K010336 02/05/2001 ADVANTAGE WINDOWS CT/PET FUSION GE MEDICAL SYSTEMS, INC.
K970606 02/18/1997 COMPUTED TOMOGRAPHY X-RAY SYSTEM GE MEDICAL SYSTEMS
K990550 02/22/1999 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC.
K050489 02/25/2005 INNOVA 2100 GE MEDICAL SYSTEMS, LLC
K020796 03/12/2002 CARD IQ ANALYSIS II GE MEDICAL SYSTEMS
K000802 03/13/2000 SPIRAL IMAGING OPTION GE MEDICAL SYSTEMS
K961055 03/18/1996 CT PROSPEED CT/I GE MEDICAL SYSTEMS
K030874 03/20/2003 GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO.
K060779 03/22/2006 ADVANCE VESSEL ANALYSIS II GE HEALTHCARE
K021016 03/29/2002 AMX-4 PLUS MOBILE X-RAY SYSTEM GE MEDICAL SYSTEMS
K031261 04/21/2003 CARD EP GE MEDICAL SYSTEMS
K111142 04/22/2011 ECHOSOFT(TM) ECHOMETRIX LLC
K061163 04/26/2006 INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT GE MEDICAL SYSTEMS, LLC
K031396 05/02/2003 ADVANTAGE WORKSTATION PASTING 1.1 GE MEDICAL SYSTEMS
K971668 05/06/1997 SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS GE MEDICAL SYSTEMS
K971667 05/06/1997 CARDIAC PHASED ARRAY COIL GE MEDICAL SYSTEMS
K021491 05/09/2002 HISPEED DUAL GE MEDICAL SYSTEMS, INC.
K041270 05/12/2004 CT COLONOGRAPHY II GENERAL ELECTRIC MEDICAL SYSTEMS
K041267 05/12/2004 CARDIQ ANALYSIS III GENERAL ELECTRIC MEDICAL SYSTEMS
K061370 05/17/2006 CARDIQ FUSION GE HEALTHCARE
K991716 05/20/1999 HISPEED NX/I CT SCANNER SYSTEM GE MEDICAL SYSTEMS, INC.
K011604 05/24/2001 PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI GE MEDICAL SYSTEMS, INC.
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
K021780 05/30/2002 ADVANTAGE SIM 6.0 GENERAL ELECTRIC MEDICAL SYSTEMS
K982004 06/08/1998 CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS GENERAL ELECTRIC CO.
K041543 06/08/2004 GE DISCOVERY ST GE HEALTHCARE
K061587 06/08/2006 FULLCARD ANALYSIS GE HEALTHCARE
K061625 06/12/2006 AUTOBONE2 GE HEALTHCARE
K992066 06/18/1999 REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM GE MEDICAL SYSTEMS
K972296 06/19/1997 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS, INC.
K982196 06/22/1998 DIGITAL RADIOGRAPHIC IMAGING SYSTEM GE MEDICAL SYSTEMS
K051673 06/23/2005 XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS
K992135 06/24/1999 SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC.
K972399 06/26/1997 ADVANTAGE WINDOWS VOLUME RENDERING OPTION GE MEDICAL SYSTEMS, INC.
K001946 06/26/2000 NEUROVASCULAR ARRAY COIL GE MEDICAL SYSTEMS, INC.
K022240 07/11/2002 MOBILE MILLENNIUM MG SYSTEM GE MEDICAL SYSTEMS, INC.
K953250 07/12/1995 SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE GE MEDICAL SYSTEMS
K012200 07/13/2001 1.5T INFINITY TWINSPEED MR SYSTEM GE MEDICAL SYSTEMS
K041921 07/16/2004 GE SIGNA PROFILE 6 INCH GP COIL GE MEDICAL SYSTEMS, LLC
K022322 07/17/2002 INNOVA AND INNOVA 2000 S GE MEDICAL SYSTEMS, INC.
K972704 07/18/1997 KINEMATIC POSITIONERS GE MEDICAL SYSTEMS, INC.
K022397 07/23/2002 SIGNA 3.0T MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS
K042053 07/30/2004 INNOVA 4100, INNOVA 3100 GE MEDICAL SYSTEMS, INC.
K982772 08/07/1998 SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL GE MEDICAL SYSTEMS, INC.
K052157 08/08/2005 INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ GE MEDICAL SYSTEMS, LLC
K963179 08/14/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K973039 08/14/1997 LEGACY/LEGACY-D TABLE GE MEDICAL SYSTEMS
K992746 08/16/1999 SIGNA HFO/I MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS, INC.
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
K963345 08/26/1996 ADVANTAGE WINDOWS TISSUE VOLUME OPTION GE MEDICAL SYSTEMS
K052345 08/26/2005 ADVANTAGE SIM MD GE HEALTHCARE
K963429 08/30/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K973270 09/02/1997 LEG'MAP OPTION GE MEDICAL SYSTEMS, INC.
K052412 09/02/2005 INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE HEALTHCARE
K022919 09/04/2002 SMART BREATH RESPIRATORY COMPENSATION OPTION GE MEDICAL SYSTEMS
K973368 09/08/1997 STRAIT'MAP OPTION GE MEDICAL SYSTEMS, INC.
K983139 09/08/1998 SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL GE MEDICAL SYSTEMS
K032795 09/08/2003 GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS, LLC
K993037 09/09/1999 LCV+ VERSION 2 GE MEDICAL SYSTEMS, INC.
K983256 09/16/1998 ADVANTAGE WINDOWS (AW) FUSION GE MEDICAL SYSTEMS
K993090 09/16/1999 SILHOUETTE FC GE MEDICAL SYSTEMS, INC.
K954353 09/18/1995 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GENERAL ELECTRIC CO.
K954354 09/18/1995 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GENERAL ELECTRIC CO.
K032915 09/22/2003 ADVANTAGE 4D OPTION GE MEDICAL SYSTEMS, LLC
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
K033168 09/30/2003 GE 0.2T SIGNA PROFILE/I MR SYSTEM GENERAL ELECTRIC CO.
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
K033244 10/07/2003 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION GE MEDICAL SYSTEMS, INC.
K954874 10/24/1995 SPECTEF PROTOCOL GE MEDICAL SYSTEMS
K052978 10/24/2005 GE 1.5T SIGNA HDE MR SYSTEM GE MEDICAL SYSTEMS, LLC
K052995 10/25/2005 ADVANTAGE WORKSTATION 4.3. GE HEALTHCARE
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
K993645 10/28/1999 CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM GE MEDICAL SYSTEMS, INC.
K964306 10/29/1996 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GENERAL ELECTRIC CO.
K993665 10/29/1999 LEGEND CRF FLUORO AND RAD SYSTEM GE MEDICAL SYSTEMS, INC.
K964370 11/01/1996 MAGNETIC RESONANCE DIAGNOSTIC SYSTEM GE MEDICAL SYSTEMS
K003408 11/02/2000 CT CORD IQ OPTION 1.0 GE MEDICAL SYSTEMS
K063324 11/03/2006 PET VCAR GE HEALTHCARE
K013636 11/05/2001 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE MEDICAL SYSTEMS
K993792 11/09/1999 SMART VESSEL ANALYSIS (SMART VA) OPTION GE MEDICAL SYSTEMS, INC.
K993791 11/09/1999 CT PERFUSION OPTION GE MEDICAL SYSTEMS, INC.
K043112 11/10/2004 GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM GENERAL ELECTRIC CO.
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
K003573 11/20/2000 DIFFUSION TENSOR IMAGING OPTION GE MEDICAL SYSTEMS, INC.
K003613 11/22/2000 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL GE MEDICAL SYSTEMS
K043262 11/24/2004 GE SIGNA EXCITE MR SURGICAL OPTION GE HEALTHCARE
K964746 11/26/1996 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION GE MEDICAL SYSTEMS
K023943 11/26/2002 CT COLONOGRAPHY GE MEDICAL SYSTEMS, INC.
K023988 12/02/2002 GE DISCOVERY LS SYSTEM GE MEDICAL SYSTEMS
K033867 12/12/2003 GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS GENERAL ELECTRIC CO.
K024137 12/16/2002 JUPITER PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS, INC.
K974715 12/17/1997 ADVANTAGE 3D XR GE MEDICAL SYSTEMS
K024200 12/20/2002 INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION) GE MEDICAL SYSTEMS, INC.
K003947 12/21/2000 FUNCTIONAL BRAIN MAPPING OPTION FOR MRI GE MEDICAL SYSTEMS
K003946 12/21/2000 SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL GE MEDICAL SYSTEMS
K041476 06/03/2004 GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM GE MEDICAL SYSTEMS, LLC
K023178 09/23/2002 INNOVA 4100 GE MEDICAL SYSTEMS, INC.
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
K970628 02/19/1997 GE ADVANTAGE DIGITIZER WORKSTATION GE MEDICAL SYSTEMS, INC.
K962738 07/15/1996 MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS GE MEDICAL SYSTEMS
K052293 08/23/2005 GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM GE MEDICAL SYSTEMS, LLC
K033400 10/24/2003 SENO ADVANTAGE GE MEDICAL SYSTEMS W-400
K033504 11/05/2003 GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GENERAL ELECTRIC CO.
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


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