FDA 510(k) Applications for Medical Device Product Code "DQK"
(Computer, Diagnostic, Programmable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| 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 |
| K212061 | Abbott | EnSite X EP System | 10/22/2021 |
| K221213 | Abbott | EnSite X EP System | 08/18/2022 |
| K210392 | Abbott | WorkMate Claris System | 03/11/2021 |
| 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 |
| K213364 | Abbott Medical | EnSite X EP System | 11/11/2021 |
| K202066 | Abbott Medical | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled | 11/25/2020 |
| K231415 | Abbott Medical | EnSiteÖ X EP System | 08/10/2023 |
| K223094 | Abbott Medical | EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software Upgrade; EnSiteÖ X EP System TactiFlexÖ Ablation Catheter, Sensor EnabledÖ, Software License | 12/27/2022 |
| K220243 | Abbott Medical | Ultiri Measurement System | 04/30/2022 |
| K203084 | Ablacon, Inc. | Ablamap Software | 08/31/2021 |
| K230008 | Ablacon, Inc. | Ablamap« System | 06/08/2023 |
| K231091 | Acutus Medical Inc | AcQMap High Resolution Imaging and Mapping System | 07/10/2023 |
| K222209 | Acutus Medical Inc. | AcQMap High Resolution Imaging and Mapping System | 10/17/2022 |
| K201015 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 12/01/2020 |
| K210680 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 08/05/2021 |
| K212345 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 08/27/2021 |
| K220784 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 07/01/2022 |
| 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 |
| K193013 | Acutus Medical, Inc. | AcQMap High Resolution Imaging and Mapping System | 02/11/2020 |
| K230606 | Acutus Medical, Inc. | AcQMap« High Resolution Imaging and Mapping System | 05/02/2023 |
| K143449 | ADAMS MEDITECH LLC | ADH 200 Analyzer Software | 06/26/2015 |
| K212662 | AliveCor, Inc. | AliveCor QT Service | 04/26/2022 |
| K181823 | AliveCor, Inc. | KardiaAI | 03/11/2019 |
| K201985 | AliveCor, Inc. | KardiaAI | 11/12/2020 |
| K152160 | APN Health, LLC | Navik 3D | 02/23/2016 |
| K182344 | Biofourmis Singapore Pte. Ltd. | RhythmAnalytics | 03/07/2019 |
| K213264 | Biosense Webster, Inc. | CARTO 3 EP Navigation System Version 7.2 | 10/29/2021 |
| K221112 | Biosense Webster, Inc. | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) | 08/17/2022 |
| 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 |
| K000248 | BIOSENSE WEBSTER, INC. | CARTO EP NAVIGATION SYSTEM | 05/05/2000 |
| K992968 | BIOSENSE WEBSTER, INC. | CARTO EP NAVIGATION SYSTEM | 09/29/1999 |
| 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 |
| K223733 | Biosense Webster, Inc. | CARTO« 3 EP Navigation System with CARTOSOUNDÖ 4D Version 7.4 | 02/16/2023 |
| K200484 | Biosense Webster, Inc. | CARTO« 3 EP Navigation System with Signal Processing Unit | 11/25/2020 |
| 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 |
| K231207 | Biosense Webster, Inc. | CARTOÖ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) | 09/07/2023 |
| K000190 | BIOSENSE WEBSTER, INC. | MODIFICATION TO CARTO EP NAVIGATION SYSTEM | 05/05/2000 |
| K993729 | BIOSENSE WEBSTER, INC. | MODIFICATION TO CARTO EP NAVIGATION SYSTEM | 12/03/1999 |
| 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 |
| 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 |
| K212490 | Boston Scientific Corporation | AVVIGO Guidance System II | 10/20/2021 |
| K230884 | Boston Scientific Corporation | AVVIGO'+ Multi-Modality Guidance System | 09/26/2023 |
| 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 |
| K210889 | Boston Scientific Corporation | iLab Polaris Multi-Modality Guidance System | 06/25/2021 |
| 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 |
| 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 |
| K213861 | CardioCalm Srl | CER-S | 04/25/2022 |
| 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 |
| K201094 | CardioNXT, Inc. | iMap 3D Mapping & Navigation System (iMap System) | 08/16/2021 |
| 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 |
| K223787 | Cath Vision ApS | ECGenius System | 08/04/2023 |
| 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 |
| K220306 | CathVision ApS | ECGenius System | 05/03/2022 |
| K230309 | Centerline Biomedical, Inc. | Intra-Operative Positioning System (IOPS«) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1) | 06/21/2023 |
| 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 |
| K022596 | CLOVER HI-TECH INC. | BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) | 01/31/2003 |
| K201060 | Cordiana Medical Informatics AG | Cordiana Dx16 | 11/16/2020 |
| K201881 | Coroventis Research AB | CoroFlow Cardiovascular System | 11/13/2020 |
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| K211465 | Edwards Lfesciences | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | 07/08/2021 |
| K223127 | Edwards Lifeciences, LLC | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | 11/07/2022 |
| K231035 | Edwards Lifesciences LLC | FusedCO Algorithm | 07/12/2023 |
| K191089 | Edwards LifeSciences, LLC | Edwards Pressure Cable | 06/13/2019 |
| K223865 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | 06/09/2023 |
| K203687 | Edwards lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index | 05/28/2021 |
| 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 |
| K213682 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, A | 06/22/2022 |
| K190205 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | 08/29/2019 |
| K221704 | Edwards Lifesciences, LLC | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | 11/22/2022 |
| K230579 | Edwards Lifesciences, LLC | Smart Wedge algorithm | 08/18/2023 |
| K201446 | Edwards Lifesiences, LLC | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | 10/01/2020 |
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