FDA 510(k) Applications Submitted by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

FDA 510(k) Number Submission Date Device Name Applicant
K790139 01/19/1979 MONITOR, OFFICE MODEL 140 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K790144 01/19/1979 TELEMETRY SYSTEM 315 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780176 02/03/1978 DISPLAY SYSTEM MODEL 428 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K780177 02/03/1978 FETAL MONITOR MODEL 112 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K820416 02/16/1982 #505 PORT. VITAL FUNCTIONS NEONATAL MON GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K820417 02/16/1982 #506 PORT. VITAL FUNCTIONS NEONATAL MON GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K840667 02/17/1984 LINEAR SCANNER 640 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K790418 02/28/1979 MODEL 8100 PRE-FILLED INTRAUTERINE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K841477 04/09/1984 COROMETRICS 815 FETAL ECG RECORDER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K831744 05/31/1983 TRANSCUTANEOUS OXYGEN MONITOR OPTION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K842261 06/07/1984 OB ULTRASOUND LINEAR SCANNER 630 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K831852 06/09/1983 FETAL MONITOR #115 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K833552 10/14/1983 TREND PROCESSOR OPTION FOR #515 NEONAT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K823210 10/28/1982 MODEL 525 NEO-TRAK NEONATAL RECORDER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K827176 11/02/1982 MODEL 640 LINEAR SCANNER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K792669 12/27/1979 COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K823904 12/28/1982 MODEL 515 NEO-TRAK NEONATAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K030575 02/24/2003 MODIFICATION TO SOLAR 9500 INFORMATION MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042642 09/27/2004 AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033964 12/22/2003 SOLAR 9500 INFORMATION MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K080251 01/31/2008 APEXPRO TELEMETRY SYSTEMS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K903316 07/25/1990 ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K904358 09/24/1990 MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K900001 01/02/1990 COROMETRICS MODEL 556 NEONATAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K910153 01/14/1991 UST-974-5 CONVEX TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K900302 01/22/1990 UMBILICAL CORD BLOOD SAMPLING KIT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K910260 01/22/1991 COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K920374 01/29/1992 ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K920376 01/29/1992 COROMETRICS MODEL 150 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K910665 02/11/1991 MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K900805 02/21/1990 ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K911310 03/18/1991 COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K891595 03/20/1989 MODEL 116 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K901335 03/22/1990 ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K911309 03/25/1991 UST-974-5 CONVEX TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K932077 04/29/1993 MODEL 151 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K894958 08/07/1989 MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K895045 08/09/1989 MODEL 410T TELECOMMUNICATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K895449 08/23/1989 ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905856 10/15/1990 MODEL 556 MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K934959 10/15/1993 MODEL 118 FETAL/MATERNAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905252 11/23/1990 ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905295 11/27/1990 CATALOG NUMBER 2609 LEG PLATE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905369 11/29/1990 UST-2266U-5 CW DOPPLER TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905391 11/30/1990 UST-969-5 CONVEX TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K896755 12/01/1989 ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K905535 12/10/1990 ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042525 09/17/2004 CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K043415 12/13/2004 CENTRICITY PACS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K090702 03/17/2009 MODIFICATION TO DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031561 05/19/2003 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032513 08/14/2003 T-WAVE ALTERNANS (TWA) ALGORITHM OPTION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K040559 03/03/2004 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032346 07/30/2003 UNITY NETWORK IS PATIENT VIEWER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032369 08/01/2003 MODIFICATION TO: APEXPRO TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033365 10/21/2003 APEXPRO FH TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033672 11/24/2003 MODIFICATION TO UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042782 10/06/2004 SEER MC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K871490 04/14/1987 COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K881834 04/29/1988 MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K873452 08/27/1987 MODIFIED MODEL SSD-650 SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K873791 09/17/1987 MODEL 500E INFANT MONITORING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K092369 08/05/2009 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K093141 10/05/2009 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K073462 12/10/2007 MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K092027 07/06/2009 CARESCAPE MONITOR B850 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K021135 04/09/2002 MODEL 2120IS SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K012718 08/15/2001 MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K880217 01/20/1988 SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K880419 02/01/1988 MODEL 800 O.B. DATA ARCHIVAL SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K850504 02/08/1985 COROMETRICS 500 INFANT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K870607 02/11/1987 "SSD-725" ULTRASOUND SECTOR SCANNER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K870916 03/06/1987 SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K851252 03/27/1985 COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K871400 04/08/1987 SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K861407 04/15/1986 NEO-TRAK 502 INFANT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K852076 05/13/1985 MODEL 145 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K861861 05/14/1986 "515A NEO-TRAK NEONATAL MONITOR" GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K861931 05/20/1986 "645OB SECTOR/LINEAR ULTRASOUND SCANNER" GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K882966 07/15/1988 MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K843385 08/28/1984 COROMETRICS 115 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K843918 10/05/1984 COROMETRICS FETAL MONITOR 142 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K864135 10/21/1986 280SL IMAGING SYSTEM SMALL PARTS PROBES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K864136 10/21/1986 260SL IMAGING SYSTEM SMALL PARTS PROBES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K864151 10/23/1986 280SL IMAGING SYSTEM TRANVAGINAL PROBES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K855045 12/17/1985 MODEL 535 NEO-TRAK RECORDER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K852608 06/19/1985 SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032582 08/21/2003 UNITY NETWORK PATIENT DATA SERVER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060661 03/13/2006 MACTRODE 3 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K073203 11/13/2007 CARESCAPE V100 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K030431 02/10/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K071073 04/16/2007 SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031320 04/25/2003 EK-PRO ARRHYTHMIA DETECTION ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032370 08/01/2003 CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K120770 03/14/2012 QT GUARD PLUS ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K083639 12/09/2008 MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032577 08/21/2003 MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033492 11/04/2003 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050614 03/10/2005 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050731 03/21/2005 SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060833 03/27/2006 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051026 04/22/2005 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K071982 07/19/2007 MODIFICATION TO: UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042177 08/11/2004 MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K062976 09/29/2006 MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K081437 05/22/2008 MAC 1600 ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K964770 11/27/1996 COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K955559 12/06/1995 COROMETRICS FETAL MOVEMENT DETECTION KIT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K962781 07/17/1996 COROMETRICS MODEL 510 AND 511 MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K102426 08/25/2010 CARESCAPE MODEL V100 VITAL SIGNS MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K082851 09/29/2008 MULTLINK CABLE AND LEADWIRE SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K040458 02/23/2004 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050583 03/07/2005 MODEL 250 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K031376 05/01/2003 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K021435 05/06/2002 DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022193 07/05/2002 DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K032252 07/22/2003 MODEL 120 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022482 07/29/2002 SENSA-CUFF, MODELS INFANT, CHILD, ADULT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K022834 08/26/2002 DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K033304 10/14/2003 MODIFICATION TO DASH 3000/4000 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K072502 09/06/2007 MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K060307 02/07/2006 12 RL ALGORITHM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K861538 04/24/1986 860 COLOR DOPPLER OR COLORVIEW 860 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K980756 02/27/1998 COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K943308 07/08/1994 MODEL 510 INFANT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K993751 11/05/1999 COROMETRICS MODEL 173 FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K942170 05/04/1994 MODEL 511 INFANT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K083750 12/17/2008 CAPNOSTAT / CAPNOFLEX CO2 SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K050093 01/14/2005 MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051518 06/08/2005 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K053356 12/02/2005 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K080157 01/23/2008 DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K020022 01/03/2002 DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K014255 12/26/2001 DINAMAP PROCARE SERIES MONITOR; MODEL 100, 200, 300, 400 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K012915 08/30/2001 DINAMAP PRO 1000 MONITOR, MODEL 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K051367 05/25/2005 PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact