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 |
| K201148 | Abbott Medical | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License | 06/26/2020 |
| K201181 | Abbott Medical | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System | 06/26/2020 |
| K193013 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 02/11/2020 |
| K170948 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 10/16/2017 |
| 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 |
| 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 |
| K201178 | Boston Scientific | iLab Polaris Multi-Modality Guidance System | 05/29/2020 |
| 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 |
| K201713 | Boston Scientific Corporation | AVVIGO Guidance System | 07/23/2020 |
| 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 |
| K192438 | Boston Scientific Corporation | Rhythmia HDxTM Mapping System | 11/27/2019 |
| 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 |
| K200313 | Catheter Precision, Inc. | VIVO | 09/14/2020 |
| 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 |
| 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 |
| K130155 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. | MUSE CARDIOLOGY INFORMATION SYSTEM | 03/01/2013 |
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| 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 |
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| 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 |
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| K081484 | MENNEN MEDICAL LTD. | HORIZON XVU | 06/20/2008 |
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| K152864 | MERGE HEALTHCARE INCORPORATED | Merge Hemo | 04/07/2016 |
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