FDA 510(k) Applications for Medical Device Product Code "DQK"
(Computer, Diagnostic, Programmable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K932954 | A-VOX SYSTEMS, INC. | AVOXIMETER | 12/27/1993 |
| K183128 | Abbott | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | 12/12/2018 |
| K182644 | Abbott | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | 10/19/2018 |
| K161240 | Abbott Electrophysiology | Rhythm View Workstation (non-streaming) | 08/10/2016 |
| K171583 | Abbott Electrophysiology | RhythmView Workstation | 09/01/2017 |
| K181577 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 02/07/2019 |
| K190131 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 04/02/2019 |
| K191392 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 09/06/2019 |
| K170948 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 10/16/2017 |
| K143449 | ADAMS MEDITECH LLC | ADH 200 Analyzer Software | 06/26/2015 |
| K905248 | ADVANCED TECHNOLOGY LABORATORIES, INC. | NOVA MICROSONICS CAPRICORN DIGITAL IMAGE SYSTEMS | 02/28/1991 |
| K930806 | AGILENT TECHNOLOGIES | ZYMED HOLTER SCANNER MODEL 2010 | 04/25/1994 |
| K181823 | AliveCor, Inc. | KardiaAI | 03/11/2019 |
| K152160 | APN Health, LLC | Navik 3D | 02/23/2016 |
| K931900 | ARCHIVAL TECHNOLOGIES, INC. | COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. | 03/11/1994 |
| K925285 | B. BRAUN OF AMERICA, INC. | DUALTHERM(R) CARDIAC OUTPUT COMPUTER | 07/21/1993 |
| K780530 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | AUTOMATED PHYSIOLOGIC PROFILER | 04/28/1978 |
| K182344 | Biofourmis Singapore Pte. Ltd. | RhythmAnalytics | 03/07/2019 |
| K090017 | BIOSENSE WEBSTER, INC. | CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES | 10/13/2009 |
| K103746 | BIOSENSE WEBSTER, INC. | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD) | 01/21/2011 |
| K112007 | BIOSENSE WEBSTER, INC. | CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 | 10/05/2011 |
| K133916 | BIOSENSE WEBSTER, INC. | CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2 | 07/01/2014 |
| K173977 | Biosense Webster, Inc. | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module | 06/14/2018 |
| K173978 | Biosense Webster, Inc. | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module | 08/24/2018 |
| K170600 | Biosense Webster, Inc. | CARTO 3 EP Navigation System, Version 6.0 and Accessories | 07/25/2017 |
| K180238 | Biosense Webster, Inc. | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT | 06/01/2018 |
| K191660 | Biosense Webster, Inc. | CARTO 3 EP Navigation System, Version 7.1 and Accessories | 07/20/2019 |
| K072202 | BIOSENSE WEBSTER, INC. | CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01) | 11/19/2007 |
| K093455 | BIOSENSE WEBSTER, INC. | CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES | 12/04/2009 |
| K992968 | BIOSENSE WEBSTER, INC. | CARTO EP NAVIGATION SYSTEM | 09/29/1999 |
| K000248 | BIOSENSE WEBSTER, INC. | CARTO EP NAVIGATION SYSTEM | 05/05/2000 |
| K042681 | BIOSENSE WEBSTER, INC. | CARTO RMT EP NAVIGATION SYSTEM | 09/29/2005 |
| K091789 | BIOSENSE WEBSTER, INC. | CARTO RMT EP NAVIGATION SYSTEM V8 | 10/01/2009 |
| K020863 | BIOSENSE WEBSTER, INC. | CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM | 01/09/2003 |
| K013083 | BIOSENSE WEBSTER, INC. | CARTO XP EP NAVIGATION SYSTEM | 11/21/2001 |
| K042999 | BIOSENSE WEBSTER, INC. | CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 | 03/21/2005 |
| K093566 | BIOSENSE WEBSTER, INC. | CARTO XP EP NAVIGATION SYSTEM, VERSION 10 | 06/18/2010 |
| K070240 | BIOSENSE WEBSTER, INC. | CARTO XP EP NAVIGATION SYSTEM, VERSION 9 | 05/04/2007 |
| K120550 | BIOSENSE WEBSTER, INC. | CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) | 05/07/2012 |
| K132782 | BIOSENSE WEBSTER, INC. | CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2 | 01/24/2014 |
| K993729 | BIOSENSE WEBSTER, INC. | MODIFICATION TO CARTO EP NAVIGATION SYSTEM | 12/03/1999 |
| K000190 | BIOSENSE WEBSTER, INC. | MODIFICATION TO CARTO EP NAVIGATION SYSTEM | 05/05/2000 |
| K000332 | BIOSENSE WEBSTER, INC. | NOGA CARDIAC NAVIGATION SYSTEM | 05/04/2000 |
| K053194 | BIOSENSE WEBSTER, INC. | NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE | 03/09/2006 |
| K990494 | BIOSENSE, INC. | MODIFICATION OF NOGA | 09/03/1999 |
| K954395 | BIOSENSE, LTD. | CARTO SYSTEM | 12/21/1995 |
| K950723 | BIOSENSOR CORP. | AMBULATORY (HOLTER) RECORDING SYSTEM | 02/09/1996 |
| K950944 | BIOSENSOR CORP. | AMBULATORY (HOLTER) RECORDING SYSTEM | 06/18/1996 |
| K974192 | BIOSENSOR CORP. | BIOSENSOR HOLTER MONITOR SYSTEM | 03/04/1998 |
| K974546 | BIOSENSOR CORP. | BIOSENSOR HOLTER MONITOR SYSTEM | 03/04/1998 |
| K990956 | BIOSENSOR CORP. | BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 | 06/14/1999 |
| K180805 | BioSig Technologies | Pure EP | 08/08/2018 |
| K003362 | BOSTON SCIENTIFIC CORP. | ASTRONOMER+WITH SLD | 03/01/2001 |
| K141185 | BOSTON SCIENTIFIC CORP. | V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM | 06/06/2014 |
| K191008 | Boston Scientific Corporation | iLab Polaris Multi-Modality Guidance System | 07/02/2019 |
| K151613 | BOSTON SCIENTIFIC CORPORATION | iLab Polaris Multi-Modality Guidance System | 10/06/2015 |
| K162793 | Boston Scientific Corporation | RHYTHMIA HDx Mapping System | 03/10/2017 |
| K173837 | Boston Scientific Corporation | RHYTHMIA HDx Mapping System (with software Version 2.0) | 07/25/2018 |
| K942565 | BURDICK CORP. | ALTAIR-DISC RECORDER | 12/05/1994 |
| K945985 | BURDICK, INC. | PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 | 07/03/1995 |
| K101331 | C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION | LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE | 10/08/2010 |
| K113811 | C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION | V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM | 03/16/2012 |
| K031000 | C.R. BARD, INC. | LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 | 06/03/2003 |
| K012206 | CAMBRIDGE HEART, INC. | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM | 10/12/2001 |
| K003492 | CAMBRIDGE HEART, INC. | ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS | 01/18/2001 |
| K011324 | CAMBRIDGE HEART, INC. | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM | 05/23/2001 |
| K100362 | CAMBRIDGE HEART, INC. | CAMBRIDGE HEART OEM | 04/14/2010 |
| K983102 | CAMBRIDGE HEART, INC. | CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 | 04/12/1999 |
| K010756 | CAMBRIDGE HEART, INC. | CH 2000 CARDIAC DIAGNOSTIC SYSTEM | 04/12/2001 |
| K050225 | CAMBRIDGE HEART, INC. | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM | 04/07/2005 |
| K013032 | CAMTRONICS, LTD. | PHYSIOLOG, SERIES 95000 | 06/04/2002 |
| K131045 | CARDIAC DESIGNS, LLC | ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE | 05/29/2013 |
| K161245 | CARDIO TEK, BV | EP-TRACER System | 08/05/2016 |
| K042849 | CARDIOBIOMEDICAL CORPORATION | CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) | 01/13/2005 |
| K162440 | CARDIOINSIGHT TECHNOLOGIES, INC | CardioInsight Cardiac Mapping System | 11/04/2016 |
| K140497 | CARDIOINSIGHT TECHNOLOGIES, INC | ECVUE MAPPING SYSTEM | 11/19/2014 |
| K150990 | CardioInsight Technologies, Inc. | ECVUE Mapping System | 07/02/2015 |
| K134044 | CARDIOTEK, B.V. | EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM | 03/31/2014 |
| K153654 | CareFusion Germany 234 GmbH | Sentry WEB SmartInterp | 09/16/2016 |
| K990058 | CATHDATA, INC. | QMS MAPPING SYSTEM,MODEL 2000 | 12/15/1999 |
| K012089 | CATHEFFECTS, LLC. | CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM | 01/28/2002 |
| K183195 | Catheter Precision, Inc. | VIVO | 06/14/2019 |
| K190106 | Centerline Biomedical, Inc. | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle | 06/24/2019 |
| K023370 | CHEETAH MEDICAL INC. | CHEETAH I.V.D.S., MODEL 2002P | 12/24/2002 |
| K840875 | CLINICAL MICROSYSTEMS INTL. | MULTIVARIATE DIGITAL CARDIOGRAPH | 07/06/1984 |
| K022596 | CLOVER HI-TECH INC. | BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) | 01/31/2003 |
| K883152 | COHERENT SYSTEMS, INC. | EP-STAT | 10/13/1988 |
| K871436 | CORAZONIX CORP. | PREDICTOR | 06/19/1987 |
| K865035 | CRITICAL CARE SYSTEMS, INC. | RECORD KEEPING/DATA MANAGEMENT SYSTEM | 05/11/1987 |
| K860854 | CYGNUS OF SOUTH FLORIDA, INC. | CRITICALC | 12/08/1986 |
| K970570 | D. E. HOKANSON, INC. | NIVP3 (WINDOWS VERSION OF NIVP | 10/03/1997 |
| K072752 | DATADANCER MEDICAL SYSTEMS | BP LIMBO XL, BPTANGO XL, BP SALSA XL | 10/31/2008 |
| K961063 | DATEX MEDICAL INSTRUMENTATION, INC. | AS/3 CARDIAC OUTPUT & SVO2 MODULE | 05/31/1996 |
| K052883 | DATRIX | CARDIOSERVER | 11/01/2005 |
| K993620 | DEL MAR MEDICAL SYSTEMS, LLC. | IMPRESARIO | 11/12/1999 |
| K912728 | DIAGNOSTIC MEDICAL INSTRUMENTS | ALTAIR | 02/27/1992 |
| K911615 | DIAGNOSTIC MONITORING SOFTWARE | HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 | 01/08/1992 |
| K800766 | DIGISONICS, INC. | ECHO-COMP | 04/24/1980 |
| K151787 | EDAN INSTRUMENTS, INC. | Holter System | 01/27/2016 |
| K191089 | Edwards LifeSciences, LLC | Edwards Pressure Cable | 06/13/2019 |
| K180881 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere Pressure Cable | 11/16/2018 |
| K163381 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable | 04/14/2017 |
| K190205 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | 08/29/2019 |
| K042002 | ELA MEDICAL INC | SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER | 10/20/2004 |
| K990727 | ELA MEDICAL, INC. | SYNEFLASH & SYNEVIEW | 11/26/1999 |
| K002817 | ELA MEDICAL, INC. | SYNETEC | 05/02/2001 |
| K935186 | ELECTROPHYSIOLOGY SYSTEMS, INC. | ELECTROPHYSIOLOGY SYSTEMS, INC. EP-EASY | 01/03/1995 |
| K082421 | EMAGEON INC. | HEARTSUITE HEMODYNAMICS 7.10 | 12/17/2008 |
| K992479 | ENDOCARDIAL SOLUTIONS, INC. | ENSITE 3000 SYSTEM | 12/02/1999 |
| K001437 | ENDOCARDIAL SOLUTIONS, INC. | ENSITE 3000 SYSTEM, MODEL EE3000 | 06/07/2000 |
| K033211 | ENDOCARDIAL SOLUTIONS, INC. | ENSITE SYSTEM | 10/30/2003 |
| K042493 | ENDOCARDIAL SOLUTIONS, INC. | ENSITE SYSTEM, MODEL EE3000 | 10/15/2004 |
| K030129 | ENDOCARDIAL SOLUTIONS, INC. | MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 | 04/22/2003 |
| K060980 | ENDOTHELIX, INC. | VENDYS MODEL 5000 B/BC | 08/16/2007 |
| K072919 | ENDOTHELIX, INC. | VENDYS, MODEL 6000 B B/C | 11/02/2007 |
| K063113 | EP MEDSYSTEMS | EP-WORKMATE | 10/27/2006 |
| K070706 | EP MEDSYSTEMS | EP-WORKMATE | 04/11/2007 |
| K032225 | EP MEDSYSTEMS | EP-WORKMATE WITH RPM SYSTEM | 08/20/2003 |
| K994011 | EP MEDSYSTEMS, INC. | EP MEDSYSTEMS, EP-WORKMATE | 03/23/2000 |
| K063277 | EP MEDSYSTEMS, INC. | MAPMATE | 11/30/2006 |
| K013349 | EP TECHNOLOGIES, INC. | ASTRONOMER PLUS SYSTEM | 04/09/2002 |
| K181720 | Epiphany Healthcare, LLC | Epiphany Cardio Server Mobile | 07/30/2018 |
| K872928 | FIDELITY MEDICAL, INC. | LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPH | 01/06/1988 |
| K012947 | FLORENCE MEDICAL LTD. | SMARTFLOW | 10/02/2001 |
| K020127 | FLORENCE MEDICAL LTD. | SMARTFLOW PULSE TRANSMISSION COEFFICIENT | 02/14/2002 |
| K030145 | GALIX BIOMEDICAL INSTRUMENTATION, INC. | GALIX WINTER | 09/17/2003 |
| K052977 | GE HEALTHCARE | DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES | 11/22/2005 |
| K052976 | GE HEALTHCARE | DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES | 01/13/2006 |
| K111200 | GE HEALTHCARE | MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM | 10/12/2011 |
| K061741 | GE HEALTHCARE | MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM | 09/15/2006 |
| K042148 | GE MEDICAL SYST. INFORMATION TECHNOLOGIES | HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES | 12/03/2004 |
| K031561 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | CARDIOSOFT/CASE CARDIAC TESTING SYSTEM | 08/01/2003 |
| K050093 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM | 05/13/2005 |
| K051026 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MARS HOLTER ANALYSIS WORKSTATION | 07/19/2005 |
| K093141 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MARS HOLTER ANALYSIS WORKSTATION | 12/29/2009 |
| K032577 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM | 10/10/2003 |
| K072502 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM | 11/19/2007 |
| K050614 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MUSE CARDIOLOGY INFORMATION SYSTEM | 04/05/2005 |
| K083639 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE | 02/17/2009 |
| K032513 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | T-WAVE ALTERNANS (TWA) ALGORITHM OPTION | 10/30/2003 |
| K103678 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GMBH | CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM | 02/16/2011 |
| K130626 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS | 05/01/2013 |
| K132437 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MARS HOLTER ANALYSIS WORKSTATION | 12/04/2013 |
| K130155 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MUSE CARDIOLOGY INFORMATION SYSTEM | 03/01/2013 |
| K152993 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MUSE Cardiology Information System | 01/12/2016 |
| K110132 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MUSE CARDIOLOGY INFORMATION SYSTEM | 05/25/2011 |
| K810750 | GENERAL ELECTRIC CO. | PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE | 03/27/1981 |
| K014108 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MAC 5000 ECG ANALYSIS SYSTEM | 01/10/2002 |
| K992948 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MAC-LAB SYSTEM | 11/29/1999 |
| K001305 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM | 06/27/2000 |
| K021366 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | MAC-LAB/CARDIOLAB EP/COMBOLAB | 07/03/2002 |
| K023380 | GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN | T-WAVE ALTERMANS (TWA) ALGORITHM OPTION | 12/03/2002 |
| K051471 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIODAY | 06/29/2005 |
| K130516 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIODAY | 08/23/2013 |
| K162023 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CardioDay V2.5 | 03/24/2017 |
| K070280 | GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG | CARDIODAY, VERSION 2.0 | 02/23/2007 |
| K810731 | GOULD, INC. | MODEL IM1000 INTEGRATED MONITOR | 03/27/1981 |
| K953127 | HEWLETT-PACKARD CO. | ACCUSTRESS EXERCISE TESTING SYSTEM | 02/29/1996 |
| K905100 | HEWLETT-PACKARD CO. | HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST | 01/15/1991 |
| K780768 | HEWLETT-PACKARD CO. | MODEL 5621A INTERFACE | 05/26/1978 |
| K874171 | HEWLETT-PACKARD CO. | MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM | 02/05/1988 |
| K961009 | HEWLETT-PACKARD CO. | STRESSWRITER EXERCISE TESTING SYSTEM | 06/17/1996 |
| K896017 | HIGHTECH VISION | THE OPHTHIMUS SYSTEM | 10/02/1990 |
| K941762 | HOGAN & HARTSON | INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) | 02/22/1995 |
| K792677 | HONEYWELL, INC. | DATABASE MANAGEMENT & REPORTING SYSTEM | 01/04/1980 |
| K760767 | HONEYWELL, INC. | MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM | 10/13/1976 |
| K053369 | HUNTLEIGH HEALTHCARE | MEDILOG DARWIN HOLTER ANALYSIS | 12/22/2005 |
| K071911 | INNOVISION A/S | CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR | 09/07/2007 |
| K051907 | INNOVISION A/S | INNOCOR | 03/02/2006 |
| K770705 | INSTRUMENTS FOR CARDIAC RESEARCH | CARDIAC ACQUISITION SYSTEM, ICR 2001 | 06/02/1977 |
| K900814 | INTELLIMETRICS INSTRUMENT CORP. | CATH LAB AUTOMATED INTERACTIVE RECORDER SYSTEMS | 12/17/1990 |
| K842339 | INTL. MEDICAL, INC. | COMPUSTRESS STRESS TESTING SYS | 12/19/1984 |
| K792525 | IREX CORP. | IREX CARDIOPLAN | 12/27/1979 |
| K091075 | IRHYTHM TECHNOLOGIES, INC. | ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM | 07/21/2009 |
| K142681 | iRhythm Technologies, Inc. | ZEUS (ZIO ECG Utilization Service) System | 11/21/2014 |
| K181502 | iRhythm Technologies, Inc. | Zio AT ECG Monitoring System, ZEUS System | 08/29/2018 |
| K190593 | iRhythm Technologies, Inc. | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | 08/23/2019 |
| K032519 | ITAMAR MEDICAL | ENDO PAT 2000 | 11/12/2003 |
| K001852 | ITAMAR MEDICAL (C.M.) 1997 LTD. | PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE | 02/21/2001 |
| K945068 | J-F MEDICAL SYSTEMS INTL., INC. | OMEGA CARES SYSTEM | 01/25/1996 |
| K812354 | KONTRON INSTRUMENTS, INC. | KONTRON PMS 7000 | 09/25/1981 |
| K800092 | KT MEDICAL, INC. | COMBISON COMPUTER | 04/08/1980 |
| K012825 | LEV-EL, LTD. | HEARTTRENDS | 03/19/2002 |
| K123466 | LUMEDX | HEALTHVIEW ECG MANAGER | 12/20/2012 |
| K922171 | MARQUETTE ELECTRONICS, INC. | CENTRA II ANALYSIS SYSTEM | 12/28/1992 |
| K855055 | MARQUETTE ELECTRONICS, INC. | PDS 9000 PATIENT DATA MGMT. SYSTEM | 02/12/1986 |
| K113515 | MCKESSON ISRAEL LTD. | HORIZON CARDIOLOGY ECG MANAGEMENT | 03/16/2012 |
| K133534 | MCKESSON ISRAEL LTD. | MCKESSON CARDIOLOGY ECG MOBILE | 04/18/2014 |
| K061905 | MEDCON LTD. | HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 | 11/08/2006 |
| K050561 | MEDCON LTD. | WINDSURFER | 05/04/2005 |
| K033266 | MEDICAL IMAGING APPLICATIONS LLC | VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS | 12/16/2004 |
| K952846 | MEDICOMP, INC. | EPICARDIA | 09/18/1995 |
| K881770 | MEDICOMP, INC. | EPICARDIA LE/FD | 05/31/1988 |
| K091781 | MEDIGUIDE, LTD. | GUIDED MEDICAL POSITIONING SYSTEM (GMPS) | 10/16/2009 |
| K102905 | MEDIGUIDE, LTD. | GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) | 10/29/2010 |
| K002869 | MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES | LOCALISA CARDIAC NAVIGATION SYSTEM | 03/27/2001 |
| K181918 | Medtronic, Inc. | CardioInsight Cardiac Mapping System | 11/08/2018 |
| K071348 | MENNEN MEDICAL LTD. | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM | 09/07/2007 |
| K043564 | MENNEN MEDICAL LTD. | HORIZON ANGIO CATHLAB | 01/27/2005 |
| K070254 | MENNEN MEDICAL LTD. | HORIZON SE | 04/19/2007 |
| K081484 | MENNEN MEDICAL LTD. | HORIZON XVU | 06/20/2008 |
| K091165 | MENNEN MEDICAL LTD. | HORIZON XVU | 08/07/2009 |
| K152864 | MERGE HEALTHCARE INCORPORATED | Merge Hemo | 04/07/2016 |
| K922528 | MICROMEDICAL INDUSTRIES, LTD. | CMS SYSTEM | 05/12/1995 |
| K161465 | MORTARA INSTRUMENT, INC. | CardioConfirm | 09/03/2016 |
| K952969 | NEW PRODUCT DEVELOPMENT, INC. | EIDOS 5003 HOLTER SYSTEM | 07/16/1996 |
| K952164 | NEW YORK HEART INSTRUMENTS, INC. | EMI MODEL FFF-IA | 05/10/1995 |
| K942771 | NON-INVASIVE MONITORING SYSTEMS, INC. | RESPIEVENTS | 02/13/1996 |
| K012020 | NON-INVASIVE MONITORING SYSTEMS, INC. | RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC | 08/21/2001 |
| K001369 | NON-INVASIVE MONITORING SYSTEMS, INC. | RESPIEVENTS, VERSION 4.2 | 07/26/2000 |
| K942852 | NON-INVASIVE MONITORING SYSTEMS, INC. | RESPITRACE PT | 02/13/1996 |
| K930564 | NORTHEAST MONITORING, INC. | HOLTER FOR WINDOWS | 04/19/1995 |
| K780468 | NUMONICS CORP. | CLINICAL GRAPHICS ANALYZER | 06/19/1978 |
| K950988 | OMEGA MEDICAL SERVICES, INC. | HOLTER 6000 | 01/04/1996 |
| K002544 | OXFORD INSTRUMENTS | MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM | 09/13/2000 |
| K920295 | OXFORD MEDILOG, INC. | MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) | 08/18/1992 |
| K120855 | PHILIPS HEALTHCARE | INTELLISPACE ECG | 06/29/2012 |
| K121638 | PHILIPS HEALTHCARE | ST80I STRESS TEST SYSTEM | 07/18/2012 |
| K180940 | Philips Medical Systems Nederland B.V. | KODEX EPD System | 10/24/2018 |
| K021495 | PIE MEDICAL IMAGING B.V. | QIVA | 10/01/2002 |
| K880879 | PPG INDUSTRIES, INC. | WORKSTATION PLUS W/LOCAL AREA NETWORK(LAN) OPTION | 06/02/1988 |
| K914577 | PRECISION HEALTH CARE SYSTEMS, INC. | RHYTHMSCAN PRECISION 6000 | 05/08/1992 |
| K992703 | PREMIER HEART, LLC. | CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800 | 03/21/2000 |
| K023112 | PROBLEM SOLVING CONCEPTS, INC. | PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9 | 12/17/2002 |
| K913193 | PROTOCOL SYSTEMS, INC. | MODEL 100 CENTRAL STATION | 10/16/1991 |
| K902716 | PRUCKA ENGINEERING, INC. | PE ELECTROPHYSIOLOGY LAB SYSTEM (PEEP) | 09/04/1990 |
| K042799 | PULSE BIOMEDICAL, INC. | QRS-CARD CARDIOLOGY SUITE | 10/22/2004 |
| K032038 | QUINTON, INC. | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | 09/05/2003 |
| K834567 | QUINTON, INC. | Q3000 | 04/30/1984 |
| K892113 | QUINTON, INC. | Q5000 PC WORKSTATION | 05/18/1989 |
| K021906 | QUINTON, INC. | QUINTON Q-CATH, MODEL 000460 | 09/04/2002 |
| K862740 | QUINTON, INC. | QUINTON Q.CATH | 10/31/1986 |
| K782072 | QUINTON, INC. | QUINTON STATUS 1000 | 02/23/1979 |
| K042628 | RADI MEDICAL SYSTEMS AB | MODIFICATION TO: RADIANALYZER, MODEL 12711 | 01/19/2005 |
| K123984 | RADI MEDICAL SYSTEMS AB | QUANTIEN MEASUREMENT SYSTEM | 03/28/2013 |
| K092105 | RADI MEDICAL SYSTEMS AB | RADIANALYZER XPRESS | 10/09/2009 |
| K022188 | RADI MEDICAL SYSTEMS AB | RADIANALYZER, MODEL 12710 | 10/03/2002 |
| K951902 | REYNOLDS MEDICAL LTD. | PATHFINDER 700 HOLTER ANALYZER | 07/15/1996 |
| K130750 | RHYTHMIA MEDICAL, INC | RHYTHMIA MAPPING SYSTEM | 07/22/2013 |
| K042463 | ROZINN ELECTRONICS, INC. | HOLTER PLUS | 09/22/2004 |
| K973751 | SCHILLER AMERICA, INC. | MT-200 | 08/25/1998 |
| K183266 | Schwarzer CardioTek GmbH | EP-TRACER System | 03/01/2019 |
| K023015 | SCHWARZER GMBH | CARDIS | 09/25/2002 |
| K792135 | SCI-PRO, INC. | DYE CURVE EVALUATOR | 01/11/1980 |
| K180432 | Shenzhen Carewell Electronics., Ltd | AI-ECG Platform | 11/19/2018 |
| K002137 | SIEMENS ELEMA AB | CATHCOR DESKTOP | 10/05/2000 |
| K801810 | SIEMENS ELEMA AB | PACEMAKER PATIENT MGMT. SYSTEM | 02/05/1981 |
| K935043 | SIEMENS MEDICAL ELECTRONICS | SIEMENS CLINICAL WORK STATION | 04/07/1995 |
| K031970 | SIEMENS MEDICAL SOLUTIONS USA, INC. | INFINITY MEGACARE | 09/09/2003 |
| K865010 | SIEMENS MEDICAL SOLUTIONS USA, INC. | MICOR | 07/06/1987 |
| K920587 | SIEMENS MEDICAL SOLUTIONS USA, INC. | PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS | 01/15/1993 |
| K851637 | SIEMENS MEDICAL SOLUTIONS USA, INC. | SIRECUST 425, RESPECTIVELY SIRECUST 430 | 07/12/1985 |
| K150493 | Siemens Medical Solutions, Inc. | Sensis | 06/30/2015 |
| K131812 | SIEMENS MEDICAL SOLUTIONS, INC. | SENSIS, SENSIS LITE | 07/25/2013 |
| K020440 | SIEMENS MEDICAL SYSTEMS, INC. | NEWCOR | 12/03/2002 |
| K914105 | SOFTHEART, INC. | CATHWRITER(TM) | 02/26/1992 |
| K921216 | SOFTHEART, INC. | OFF-LINE ANALYSIS SYSTEM | 11/20/1992 |
| K930639 | SOFTHEART, INC. | ON-LINE ANALYSIS SYSTEM | 09/22/1993 |
| K110779 | SPACELABS HEALTHCARE | SPACELABS SMART DISCLOSURE SYSTEM | 04/19/2011 |
| K152881 | SPACELABS HEALTHCARE LTD. | SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM | 04/01/2016 |
| K110001 | SPACELABS HEALTHCARE LTD. | SPACELABS PATHFINDER SL HOLTER ANALYZER | 06/14/2011 |
| K063490 | SPACELABS MEDICAL INC. | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810 | 03/15/2007 |
| K962930 | SPACELABS MEDICAL, INC. | SPACELABS MEDICAL ECG ANALYSIS SYSTEM | 04/25/1997 |
| K791776 | SPACELABS, INC. | ARRHYTHMIA II EDITOR | 10/02/1979 |
| K850627 | SPACELABS, INC. | SPACELABS-GENERAL SYSTEM LINK | 05/28/1985 |
| K160218 | St. Jude Medical | AutoMark Module | 12/13/2016 |
| K071818 | ST. JUDE MEDICAL | ENSITE FUSION DYNAMIC REGISTRATION TOOL | 12/20/2007 |
| K082467 | ST. JUDE MEDICAL | ENSITE FUSION DYNAMIC REGISTRATION TOOL | 09/11/2008 |
| K160210 | ST. JUDE MEDICAL | EnSite Precision Cardiac Mapping System v2.0 | 12/13/2016 |
| K083328 | ST. JUDE MEDICAL | ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010 | 05/22/2009 |
| K160187 | ST. JUDE MEDICAL | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 | 10/21/2016 |
| K172396 | St. Jude Medical | EnSite Velocity Cardiac Mapping System v5.2 | 04/23/2018 |
| K160186 | ST. JUDE MEDICAL | EnSite Velocity Surface Electrode Kit | 10/07/2016 |
| K110549 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM | 05/05/2011 |
| K130594 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM | 05/03/2013 |
| K130727 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM | 08/29/2013 |
| K101328 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM | 07/14/2010 |
| K141050 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM | 06/06/2014 |
| K101667 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT) | 07/02/2010 |
| K112688 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM V.3.0 | 11/09/2011 |
| K093942 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM V1.3 | 02/25/2010 |
| K101419 | ST. JUDE MEDICAL | ENSITE VELOCITY SYSTEM, MODEL EE3000 | 06/11/2010 |
| K093583 | ST. JUDE MEDICAL | EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE | 12/15/2009 |
| K092810 | ST. JUDE MEDICAL | EP-WORKMATE SYSTEM, VERSION 4.2 | 10/09/2009 |
| K132073 | ST. JUDE MEDICAL | EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE | 09/09/2013 |
| K162643 | ST. JUDE MEDICAL | MediGuide Technology System | 12/13/2016 |
| K070902 | ST. JUDE MEDICAL | MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000 | 05/01/2007 |
| K151911 | ST. JUDE MEDICAL | WorkMate Claris System, WorkMate Claris System Display Plus | 10/22/2015 |
| K183099 | St. Jude Medical (now Abbott Medical) | QUANTIEN Measurement System | 02/28/2019 |
| K172182 | St. Jude Medical (now part of the Abbott Medical) | QUANTIEN Measurement System | 08/18/2017 |
| K060954 | ST. JUDE MEDICAL, INC.-ENDOCARDIAL SOLUTIONS | MODIFICATION TO ENSITE SYSTEM, MODEL EE3000 | 04/21/2006 |
| K120301 | ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS | MEDIGUIDE TECHNOLOGY | 02/24/2012 |
| K093092 | STEREOTAXIS, INC. | ODYSSEY WORKSTATION | 01/21/2010 |
| K142349 | Telemed Solutions, Inc. | TM eCloud ECG Analysis System | 09/21/2015 |
| K110746 | TOMTEC IMAGING SYSTEMS, GMBH | 4D LV-ANALYSIS 3.0 | 05/24/2011 |
| K103782 | TOMTEC IMAGING SYSTEMS, GMBH | 4D MV-ASSESSMENT 2.0 | 01/27/2011 |
| K001592 | TOMTEC IMAGING SYSTEMS, GMBH | ECHOCOM, IMAGECOM, DOKUCOM | 06/16/2000 |
| K123295 | TOPERA, INC. | RHYTHM VIEW | 04/24/2013 |
| K133305 | TOPERA, INC. | RHYTHM VIEW WORKSTATION | 12/16/2013 |
| K151245 | TOPERA, INC. | Rhythm View Workstation (non-streaming, steaming option) | 09/15/2015 |
| K110878 | TOPERA, INC. | RHYTHMVIEW (TM) | 09/23/2011 |
| K142901 | Topera, Inc. | RhythmView Workstation | 12/19/2014 |
| K041031 | US CLOVER CO. | CARDIOSTATION-100 (CS-100) | 01/26/2005 |
| K864583 | VASCULAR TECHNOLOGY INCORPORATED | CARDIAC PERFORMANCE MONITOR | 05/11/1987 |
| K812739 | VITALOG CORP. | VITALOG PMS-8 MONITOR | 12/29/1981 |
| K043604 | VIVOMETRICS, INC. | LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE | 04/29/2005 |
| K011903 | VIVOMETRICS, INC. | LIFESHIRT SYSTEM WITH VIVOLOGIC ANALYSIS SOFTWARE | 04/12/2002 |
| K031550 | VIVOMETRICS, INC. | REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE | 07/29/2003 |
| K955015 | ZYMED MEDICAL INSTRUMENTATION | ZYMED HOLTER SCANNER MODEL 2010 | 03/18/1996 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
