FDA 510(k) Applications for Medical Device Product Code "LNH"
(System, Nuclear Magnetic Resonance Imaging)

FDA 510(k) Number Applicant Device Name Decision Date
K031350 3TP LLC 3TP SOFTWARE OPTION 06/23/2003
K915260 A&E SPECIALTY FABRICATORS MRI ULTRAVIEW 03/16/1992
K041577 ADAC LABORATORIES PINNACLE3 RADIATION THERAPY PLANNING SYSTEM 06/25/2004
K072850 ADVANCED IMAGING LABORATORY MRI SYSTEM, MODEL MAGFINDER II / AI 3200 11/21/2007
K950837 ADVANCED MAMMOGRAPHY SYSTEMS, INC. AURORA IMAGING SYSTEM 02/26/1996
K944070 ADVANCED NMR SYSTEMS, INC. ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING 06/19/1995
K934514 ADVANCED NMR SYSTEMS, INC. CATCH AND HOLD OPTION FOR INSTASCAN 06/21/1994
K920204 ADVANCED NMR SYSTEMS, INC. INSTASCAN 08/05/1992
K052023 ALAN PENN & ASSOCIATES., INC. CADIMAS VERSION 1.0 12/08/2005
K923948 ALLIANCE PHARMACEUTICAL CORP. SAT PAD 11/06/1992
K926416 ALLIANCE PHARMACEUTICAL CORP. SAT PAD(TM) 05/19/1993
K082100 ALLTECH MEDICAL SYSTEMS AMERICA, INC. ALLTECH ECHOSTAR 1.5 T MR SYSTEM 08/06/2008
K163192 ALLTECH MEDICAL SYSTEMS AMERICA, INC. Comfort EC710 04/10/2017
K141945 ALLTECH MEDICAL SYSTEMS AMERICA, INC. ECHOSTAR COMFORT 1.5T MRI 02/03/2015
K113511 ALLTECH MEDICAL SYSTEMS AMERICA, INC. ECHOSTAR SPICA 1.5T MR SYSTEM 05/02/2012
K130692 ASPECT IMAGING LTD M2 WRIST 2 MRI SYSTEM 01/14/2014
K120701 ASPECT IMAGING LTD M2 WRIST MRI SYSTEM 02/07/2013
K160185 ASPECT IMAGING LTD Wrist 3 03/01/2016
K170978 Aspect Imaging Ltd. Embrace Neonatal MRI System 07/19/2017
K003651 AURORA IMAGING TECHNOLOGY, INC. AURORA 02/21/2001
K032082 AURORA IMAGING TECHNOLOGY, INC. AURORA 07/30/2003
K012154 AURORA IMAGING TECHNOLOGY, INC. AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE 09/19/2001
K023686 AURORA IMAGING TECHNOLOGY, INC. AURORA MR-GUIDED INTERVENTIONAL SYSTEM 01/29/2003
K073425 AURORA IMAGING TECHNOLOGY, INC. MODIFICATION TO AURORA MRI SYSTEM 09/16/2008
K052698 AURORA IMAGING TECHNOLOGY, INC. MODIFICATION TO: AURORA 11/08/2005
K032678 AURORA IMAGING TECHNOLOGY, INC. MODIFICATION TO: AURORA 09/24/2003
K921891 AVOTEC, INC. SILENT SCAN 05/13/1993
K090873 BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. I OPEN 0.5T 04/10/2009
K090433 BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. I_OPEN 0.4T 03/25/2009
K990968 BIOSOUND ESAOTE, INC. E-SCAN 05/27/1999
K020164 BIOSOUND ESAOTE, INC. E-SCAN XQ 02/12/2002
K010057 BIOSOUND ESAOTE, INC. MODIFICATION TO ARTOSCAN M 02/02/2001
K001894 BIOSOUND ESAOTE, INC. MODIFICATION TO E-SCAN 07/06/2000
K931022 BIOSOUND, INC. ARTOSCAN 10/07/1993
K963262 BIOSOUND, INC. ARTOSCAN M 03/28/1997
K911348 BRUEL & KJAER RIGID ENDOSCOPE 06/21/1991
K894714 BRUKER MEDICAL IMAGING, INC. 1989 SOFTWARE REVISION TO THE BMT-1100 11/15/1989
K903661 BRUKER MEDICAL IMAGING, INC. BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD 11/13/1990
K900026 BRUKER MEDICAL IMAGING, INC. BRUKER R28 WHOLE-BODY MR SCANNER 04/30/1990
K913463 BRUKER MEDICAL IMAGING, INC. MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN 11/29/1991
K895328 BRUKER MEDICAL IMAGING, INC. MAGNETIC RESONANCE SYSTEM MODEL BMT-1100 03/09/1990
K891760 BRUKER MEDICAL IMAGING, INC. MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED 06/23/1989
K915657 BRUKER MEDICAL IMAGING, INC. MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28 03/13/1992
K181593 Canon Medical Systems Corporation Vantage Galan 3T, MRT-3020/A7, V5.0 08/13/2018
K182282 Canon Medical Systems Corporation Vantage Orian 1.5T, MRT-1550, V4.5 10/19/2018
K982761 CHAMCO, INC. JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031 10/22/1998
K072473 CHASE MEDICAL, LP CHASE MR SYSTEM 12/10/2007
K020268 CHI, INC. ISAAC 1.5 T MR SYSTEM 04/25/2002
K070968 CHOY MEDICAL TECHNOLOGIES, INC. CHOY COMPRESSION FRAME 11/15/2007
K132381 CLEARMRI SOLUTIONS, INC. CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT 04/04/2014
K041020 CONFIRMA, INC. CADSTREAM VERSION 3.1 07/07/2004
K970037 DAUM GMBH TARGOGRID 03/12/1997
K061368 DIAGNOSOFT, INC. DIAGNOSOFT HARP 07/28/2006
K100352 DIAGNOSOFT, INC. DIAGNOSOFT HARP MODEL 2.06 03/11/2010
K934318 DIAGNOSTIC INSTRUMENT CORP. DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL 08/22/1994
K935691 DIAGNOSTIC INSTRUMENT CORP. MODEL GP-252 GENERAL PURPOSE COIL 08/01/1994
K893881 DIASONICS, INC. ACCESS TM 06/23/1989
K894290 DIASONICS, INC. ACCESS TM 09/07/1989
K884816 DIASONICS, INC. ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY 02/02/1989
K883516 DIASONICS, INC. DIASONICS MT/P IMAGING SYSTEM 10/07/1988
K891541 DIASONICS, INC. MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0. 05/11/1989
K884607 DIASONICS, INC. MT/S (SOFTWARE RELEASE 3.1) 12/21/1988
K884606 DIASONICS, INC. MT/S (SPINE TRANSMIT COIL) 12/05/1988
K884604 DIASONICS, INC. MT/S CARLSON SPINE COIL, PART # 100-50082500-01 11/30/1988
K893518 DIASONICS, INC. MT/S SOFTWARE RELEASE 5.0. 10/27/1989
K884603 DIASONICS, INC. SHOULDER TRANSMIT AND RECEIVE COILS 11/30/1988
K884743 DIASONICS, INC. TEMPOROMANDIBULAR JOINT COIL (TMJ) 12/05/1988
K992120 EKEROTH QUALITY AB DYNAWELL OR DYNAWELL 08/13/1999
K972826 ELSCINT MR, INC. ESTEEM 1.5T MRI SYSTEM 10/15/1997
K962677 ELSCINT MR, INC. ESTEEM 1.5T MRI SYSTEM 09/20/1996
K970990 ELSCINT MR, INC. GYREX PRIMA 1TG 1.0T MRI SYSTEM 08/25/1997
K915579 ELSCINT, INC. 3D PROCESSING OPTIONS FOR GYREX 02/18/1992
K923897 ELSCINT, INC. A BREAST COIL FOR THE GYREX 2T-DIX 10/21/1992
K934987 ELSCINT, INC. CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX 09/16/1994
K945791 ELSCINT, INC. GYRES 2T PRESTIGE 09/19/1995
K974614 ELSCINT, INC. GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 03/04/1998
K965044 ELSCINT, INC. GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102 06/16/1997
K980306 ELSCINT, INC. GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP 04/02/1998
K903028 ELSCINT, INC. GYREX 2T VERSION 2.1U. 09/10/1990
K915601 ELSCINT, INC. GYREX 2T-DLX 02/14/1992
K935549 ELSCINT, INC. GYREX 2T-SGR 08/24/1994
K954039 ELSCINT, INC. GYREX PRIVILEGE 11/24/1995
K925985 ELSCINT, INC. GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0 10/07/1993
K962618 ELSCINT, INC. GYREX V-EP 09/04/1996
K943320 ELSCINT, INC. HEAD AND NECK COIL FOR THE GYREX 2T-DLX 11/29/1994
K896419 ELSCINT, INC. MODEL: GYREX VERSION V 02/02/1990
K915598 ELSCINT, INC. SPECIAL PURPOSE COILS FOR GYREX V 01/31/1992
K935224 ELSCINT, INC. VOLUME NECK COIL FOR THE GYREX V-DIX 06/27/1994
K180592 Esaote S.p.A G-scan Brio 03/30/2018
K183685 Esaote S.p.A O-Scan 01/22/2019
K110802 ESAOTE S.P.A. A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 04/08/2011
K040877 ESAOTE S.P.A. ARTOSCAN C 05/04/2004
K110238 ESAOTE S.P.A. G-SCAN 02/17/2011
K133490 ESAOTE S.P.A. G-SCAN BRIO 12/30/2013
K161973 Esaote S.p.A. G-scan Brio, S-scan 10/25/2016
K032121 ESAOTE S.P.A. MODIFICATION TO E-SCAN XQ 08/13/2003
K153039 Esaote S.p.A. MRI Dynamic Analysis Plus 01/08/2016
K092469 ESAOTE S.P.A. O-SCAN MR SYSTEM 12/23/2009
K161238 Esaote S.p.A. S-scan 07/08/2016
K151668 ESAOTE S.P.A. S-scan 09/08/2015
K080968 ESAOTE S.P.A. S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA 04/29/2008
K061429 ESAOTE, S.P.A. DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA 07/25/2006
K042236 ESAOTE, S.P.A. G-SCAN 10/04/2004
K111803 ESAOTE, S.P.A. G-SCAN 07/15/2011
K122006 ESAOTE, S.P.A. G-SCAN BRIO 08/06/2012
K142421 ESAOTE, S.P.A. G-scan Brio 04/09/2015
K060956 ESAOTE, S.P.A. G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004 05/04/2006
K121650 ESAOTE, S.P.A. S-SCAN 07/09/2012
K131996 ESAOTE, S.P.A. S-SCAN 12/13/2013
K063207 ESAOTE, S.P.A. S-SCAN MRI SYSTEM 11/09/2006
K120748 ESAOTE, S.P.A. SPEEDUP SOFTWARE OPTION 05/01/2012
K982157 FIELD EFFECTS TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE 09/02/1998
K920789 FONAR CORP. B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER 06/25/1992
K883699 FONAR CORP. B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER 10/31/1988
K883648 FONAR CORP. BETA 3000M MOBILE NMR IMAGING SYSTEM 10/19/1988
K940772 FONAR CORP. ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER) 04/10/1995
K994287 FONAR CORP. FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER 03/16/2000
K002490 FONAR CORP. INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER 10/03/2000
K061930 FONAR CORP. INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY 07/28/2006
K915567 FONAR CORP. MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY) 05/15/1992
K011485 FONAR CORP. PINNACLE MAGNETIC RESONANCE IMAGING SCANNER 06/06/2001
K951681 FONAR CORP. QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER 11/09/1995
K003453 FONAR CORP. SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS 01/18/2001
K910839 FONAR CORP. ULTIMATE 3000 07/26/1991
K120778 GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355 03/27/2012
K123417 GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355, OPTIMA MR360 01/17/2013
K103330 GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO MR355, OPTIMA MR360 02/11/2011
K043262 GE HEALTHCARE GE SIGNA EXCITE MR SURGICAL OPTION 01/12/2005
K153003 GE HEALTHCARE SIGNA Pioneer 10/27/2015
K161567 GE HEALTHCARE SIGNA Voyager 09/01/2016
K160621 GE HEALTHCARE SIGNAPioneer 03/29/2016
K132376 GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T 11/15/2013
K123522 GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) OPTIMA MR450W 03/13/2013
K143251 GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC) SIGNA Creator, SIGNA Explorer 02/04/2015
K103327 GE HEALTHCARE JAPAN CORPORATION DISCOVERY MR750W 3.0T 09/30/2011
K143345 GE HEALTHCARE JAPAN CORPORATION SIGNA Pioneer 07/10/2015
K012200 GE MEDICAL SYSTEMS 1.5T INFINITY TWINSPEED MR SYSTEM 08/03/2001
K963345 GE MEDICAL SYSTEMS ADVANTAGE WINDOWS TISSUE VOLUME OPTION 10/18/1996
K031396 GE MEDICAL SYSTEMS ADVANTAGE WORKSTATION PASTING 1.1 05/13/2003
K002997 GE MEDICAL SYSTEMS FIESTA IMAGING OPTION 04/11/2001
K003947 GE MEDICAL SYSTEMS FUNCTIONAL BRAIN MAPPING OPTION FOR MRI 03/13/2001
K053009 GE MEDICAL SYSTEMS GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 11/17/2005
K031927 GE MEDICAL SYSTEMS GE DELTA SOFTWARE OPTION FOR MRI 07/02/2003
K912881 GE MEDICAL SYSTEMS GE MR MAX 09/06/1991
K895794 GE MEDICAL SYSTEMS GE MR MAX SYSTEM 11/17/1989
K031230 GE MEDICAL SYSTEMS GE PROPELLER IMAGING OPTION FOR MRI 05/02/2003
K893509 GE MEDICAL SYSTEMS GE SIGNA ADVANTAGE 08/11/1989
K901730 GE MEDICAL SYSTEMS GE SIGNA ADVANTAGE 07/06/1990
K012970 GE MEDICAL SYSTEMS GE SIGNA ASSET IMAGING OPTION 09/24/2001
K981190 GE MEDICAL SYSTEMS HIGH IMPEDANCE CARDIAC GATING CABLE 06/30/1998
K103411 GE MEDICAL SYSTEMS IDEAL IQ SOFTWARE OPTION 03/22/2011
K944979 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 06/13/1995
K944112 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 12/22/1994
K934499 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 12/23/1993
K903319 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC DEVICE 08/17/1990
K913475 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC DEVICE 10/30/1991
K962061 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 11/27/1996
K963179 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 11/07/1996
K963429 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 11/27/1996
K964370 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 01/10/1997
K950973 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 05/11/1995
K972990 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 02/05/1998
K980114 GE MEDICAL SYSTEMS MAGNETIC RESONANCE DIAGNOSTIC SYSTEM 03/30/1998
K022397 GE MEDICAL SYSTEMS SIGNA 3.0T MAGNETIC RESONANCE SYSTEM 08/22/2002
K912539 GE MEDICAL SYSTEMS SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM 09/27/1991
K911959 GE MEDICAL SYSTEMS SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF 09/10/1991
K942604 GE MEDICAL SYSTEMS SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM 11/24/1995
K923025 GE MEDICAL SYSTEMS SIGNA BREAST COIL AND ARRAY ACCESSORY 11/27/1992
K013636 GE MEDICAL SYSTEMS SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 01/24/2002
K002611 GE MEDICAL SYSTEMS SIGNA MFO/I MAGNETIC RESONANCE SYSTEM 10/31/2000
K012875 GE MEDICAL SYSTEMS SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM 11/20/2001
K945730 GE MEDICAL SYSTEMS SIGNA PROFILE 08/09/1995
K971668 GE MEDICAL SYSTEMS SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS 07/24/1997
K000802 GE MEDICAL SYSTEMS SPIRAL IMAGING OPTION 05/26/2000
K000315 GE MEDICAL SYSTEMS VENTRICULAR ANALYSIS TOOLKIT OPTION 03/27/2000
K990550 GE MEDICAL SYSTEMS, INC. 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM 05/11/1999
K003573 GE MEDICAL SYSTEMS, INC. DIFFUSION TENSOR IMAGING OPTION 01/23/2001
K972704 GE MEDICAL SYSTEMS, INC. KINEMATIC POSITIONERS 09/29/1997
K992746 GE MEDICAL SYSTEMS, INC. SIGNA HFO/I MAGNETIC RESONANCE SYSTEM 11/09/1999
K992135 GE MEDICAL SYSTEMS, INC. SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM 09/08/1999
K103238 GE MEDICAL SYSTEMS, LLC 1.5T OPTIMA MR430S 02/11/2011
K121676 GE MEDICAL SYSTEMS, LLC 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT 09/20/2012
K092925 GE MEDICAL SYSTEMS, LLC 3D ASL 01/06/2010
K073167 GE MEDICAL SYSTEMS, LLC BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER 01/04/2008
K083147 GE MEDICAL SYSTEMS, LLC DISCOVERY MR450 11/04/2008
K142361 GE MEDICAL SYSTEMS, LLC Discovery MR750 3.0T 12/05/2014
K142085 GE MEDICAL SYSTEMS, LLC DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T 09/26/2014
K160618 GE MEDICAL SYSTEMS, LLC Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T 06/09/2016
K163331 GE Medical Systems, LLC Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist 03/17/2017
K130115 GE MEDICAL SYSTEMS, LLC DISCOVERY MR750W 3.0T 05/23/2013
K032795 GE MEDICAL SYSTEMS, LLC GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM 10/08/2003
K052293 GE MEDICAL SYSTEMS, LLC GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM 09/21/2005
K052978 GE MEDICAL SYSTEMS, LLC GE 1.5T SIGNA HDE MR SYSTEM 11/09/2005
K041476 GE MEDICAL SYSTEMS, LLC GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM 06/17/2004
K081916 GE MEDICAL SYSTEMS, LLC GE SIGNA MR ONCOLOGY PACKAGE 07/22/2008
K162403 GE Medical Systems, LLC HyperBand 11/18/2016
K162722 GE MEDICAL SYSTEMS, LLC HyperSense 04/20/2017
K072998 GE MEDICAL SYSTEMS, LLC IDEAL SOFTWARE OPTION FOR GE MR SCANNERS 11/01/2007
K161397 GE Medical Systems, LLC MAGiC 08/31/2016
K113394 GE MEDICAL SYSTEMS, LLC MAVRIC SL 12/11/2012
K102155 GE MEDICAL SYSTEMS, LLC MR RADIATION ONCOLOGY OPTIONS 08/31/2010
K083421 GE MEDICAL SYSTEMS, LLC MR-TOUCH OPTION 07/24/2009
K123068 GE MEDICAL SYSTEMS, LLC OPTIMA MR 430S 11/13/2012
K113490 GE MEDICAL SYSTEMS, LLC OPTIMA MR450W 01/13/2012
K091536 GE MEDICAL SYSTEMS, LLC OPTIMA MR450W 07/17/2009
K081028 GE MEDICAL SYSTEMS, LLC SIGNA 3.0T MR750 SYSTEM 04/25/2008
K183231 GE Medical Systems, LLC SIGNA Premier 01/18/2019
K171128 GE Medical Systems, LLC SIGNA Premier 07/14/2017
K913770 GENERAL ELECTRIC CO. ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION 12/27/1991
K954355 GENERAL ELECTRIC CO. ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION 11/14/1995
K043112 GENERAL ELECTRIC CO. GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM 11/24/2004
K033168 GENERAL ELECTRIC CO. GE 0.2T SIGNA PROFILE/I MR SYSTEM 10/10/2003
K033504 GENERAL ELECTRIC CO. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 11/25/2003
K030874 GENERAL ELECTRIC CO. GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM 03/28/2003
K033867 GENERAL ELECTRIC CO. GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS 12/19/2003
K883547 GENERAL ELECTRIC CO. GE MR MAX SYSTEM 11/30/1988
K910817 GENERAL ELECTRIC CO. GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR 04/23/1991
K902663 GENERAL ELECTRIC CO. GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP 09/20/1990
K892235 GENERAL ELECTRIC CO. GE SHOULDER SURFACE COIL, CAT. #M1085AN 05/11/1989
K040444 GENERAL ELECTRIC CO. GE SIGNA 3.0T WITH EXCITE MR SYSTEM 04/14/2004
K923264 GENERAL ELECTRIC CO. GENERAL PURPOSE FLEX COIL 09/30/1992
K924349 GENERAL ELECTRIC CO. GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP 11/27/1992
K911806 GENERAL ELECTRIC CO. MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 06/28/1991
K924605 GENERAL ELECTRIC CO. MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 05/21/1993
K964306 GENERAL ELECTRIC CO. MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 01/17/1997
K954353 GENERAL ELECTRIC CO. MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 04/12/1996
K954354 GENERAL ELECTRIC CO. MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY 04/12/1996
K891769 GENERAL ELECTRIC CO. MAGNISCAN 5000 MR SYSTEM 06/15/1989
K884369 GENERAL ELECTRIC CO. POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM 11/28/1988
K921941 GENERAL ELECTRIC CO. SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT 11/09/1992
K931298 GENERAL ELECTRIC CO. SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM 01/18/1994
K941666 GENERAL ELECTRIC CO. SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS 06/19/1995
K902933 GENERAL ELECTRIC CO. TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) 08/23/1990
K946085 GENERAL ELECTRIC CO. THIN-FILM CARDIAC GATING CABLE 06/05/1995
K921653 GENERAL ELECTRIC CO. VECTRA MAGNETIC RESONANCE SYSTEM 12/24/1992
K913673 GENERAL ELECTRIC CO. VECTRA MAGNETIC RESONANCE SYSTEM 01/23/1992
K931460 GENERAL ELECTRIC CO. VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM 03/04/1994
K962249 GENERAL MEDICAL EQUIPMENT CORP. PIXELL MRI SYSTEM 01/10/1997
K911746 HEALTH IMAGES, INC. H.I.STANDARD CALIBRE UPGRADE 08/16/1991
K944724 HEALTH IMAGES, INC. HEALTH IMAGE INC. HI STAR 08/30/1995
K944228 HEALTH IMAGES, INC. HEALTH IMAGES, INC. HI-STANDARD 07/20/1995
K890092 HEALTH IMAGES, INC. HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE 06/23/1989
K964778 HEALTH IMAGES, INC. HI-STAR MRI IMAGING SYSTEM 02/24/1997
K170090 HeartVista, Inc. RTHawk, HeartVista Cardiac Package 07/14/2017
K153740 HeartVista, Inc. RTHawk, HeartVista Cardiac Package 06/30/2016
K142997 HEARTVISTA, INC. RTHawk, HeartVista Workstation with RTHawk 12/17/2014
K133848 HEARTVISTA, INC. RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK 06/25/2014
K172110 Hitachi Healthcare Americas Corporation ECHELON OVAL V6.0A MRI System 01/11/2018
K962048 HITACHI MEDICAL SYSTEMS AMERICA, INC. 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) 08/14/1996
K925009 HITACHI MEDICAL SYSTEMS AMERICA, INC. 2D TOF ANGIOGRAHY MEASURING FUNCTION 02/12/1993
K935671 HITACHI MEDICAL SYSTEMS AMERICA, INC. 2D, 3D TOF MR ANGIOGRAPHY 03/30/1994
K943800 HITACHI MEDICAL SYSTEMS AMERICA, INC. 2D,3D, TOF MR ANGIOGRAPHY 12/30/1994
K920441 HITACHI MEDICAL SYSTEMS AMERICA, INC. 3D TOF ANGIOGRAPHY MEASURING FUNCTION 07/30/1992
K961876 HITACHI MEDICAL SYSTEMS AMERICA, INC. AIRIS 07/25/1996
K945155 HITACHI MEDICAL SYSTEMS AMERICA, INC. AIRIS 05/24/1995
K032232 HITACHI MEDICAL SYSTEMS AMERICA, INC. AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE 09/29/2003
K974212 HITACHI MEDICAL SYSTEMS AMERICA, INC. AIRIS II 02/09/1998
K984280 HITACHI MEDICAL SYSTEMS AMERICA, INC. AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE 02/08/1999
K050602 HITACHI MEDICAL SYSTEMS AMERICA, INC. ALTAIRE 04/07/2005
K053309 HITACHI MEDICAL SYSTEMS AMERICA, INC. ALTAIRE INTERVENTIONAL MR PACKAGE 01/24/2006
K933645 HITACHI MEDICAL SYSTEMS AMERICA, INC. ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 11/12/1993
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