Computer, Diagnostic, Programmable
FDA product code DQK · Class II (moderate risk) · 21 CFR 870.1425 · Cardiovascular
437510(k) clearances
0PMA approvals
117recalls
Manufacturers
- Biosense Webster, Inc. 34
- St Jude Medical 23
- Ge Medical Systems Information Technologies 18
- Boston Scientific Corporation 15
- Edwards Lifesciences, LLC 15
- Abbott Medical 13
- Acutus Medical, Inc. 12
- iRhythm Technologies, Inc. 8
- Centerline Biomedical, Inc. 7
- Cambridge Heart, Inc. 7
- Quinton, Inc. 6
- Medtronic, Inc. 6
- Biosensor Corp. 5
- Topera, Inc. 5
- Hewlett-Packard Co. 5
- Ep Medsystems 5
- General Electric Medical Systems Information Techn 5
- Siemens Medical Solutions USA, Inc. 5
- Mennen Medical, Inc. 5
- Endocardial Solutions, Inc. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262005 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 08/21/2026SE |
| K253692 | AVVIGO+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific | 08/21/2026SE |
| K253576 | CorVista System® with PCWP Add-OnDQK · Traditional | Analytics For Life, Inc. | 07/26/2026SE |
| K262006 | EnSite X EP SystemDQK · Special | Abbott Medical | 07/15/2026SE |
| K252978 | ScioCardio ECG Analysis PlatformDQK · Traditional | Synergen Technology Labs, LLC | 07/09/2026SE |
| K253463 | ILR ECG Analyzer (IM007)DQK · Traditional | Implicity, Inc. | 07/02/2026SE |
| K261119 | NorthStar Mapping System (MAP01 or MAP01-01)DQK · Special | Imricor Medical Systems, Inc. | 06/30/2026SE |
| K253088 | OneStim-DUO Cardiac Stimulator (MP5003-4CO)DQK · Traditional | Micropace Pty, Ltd. | 06/12/2026SE |
| K261329 | Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…DQK · Special | Centerline Biomedical | 06/10/2026SE |
| K252859 | ZEUS Platform (FG0501US)DQK · Traditional | iRhythm Technologies, Inc. | 05/29/2026SE |
| K260212 | EnSite X EP SystemDQK · Traditional | Abbott Medical | 04/20/2026SE |
| K253861 | Acorys Mapping SystemDQK · Traditional | Corify Care S.L | 04/13/2026SE |
| K253473 | SynchronyDQK · Traditional | Stereotaxis, Inc. | 04/01/2026SE |
| K253186 | HemoSphere Nano Monitor (HSNANO1)DQK · Traditional | Edwards Lifesciences, LLC | 02/24/2026SE |
| K252972 | CARTO 3 EP Navigation System V8.4DQK · Traditional | Biosense Webster, Inc. | 02/20/2026SE |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…DQK · Traditional | Centerline Biomedical, Inc. | 02/17/2026SE |
| K251591 | Holter ECG and ABP system (HolterABP)DQK · Traditional | Edan Instruments, Inc. | 02/09/2026SE |
| K251218 | SafeBeat Rx AppDQK · Traditional | SafeBeat Rx, Inc. | 02/06/2026SE |
| K252164 | NorthStar Mapping SystemDQK · Traditional | Imricor Medical Systems | 01/28/2026SE |
| K254085 | CARTO 3 EP Navigation System V9.0 with PIU PlusDQK · Special | Biosense Webster, Inc. | 01/18/2026SE |
| K253733 | STAR Apollo Mapping SystemDQK · Special | Rhythm AI, Ltd. | 12/19/2025SE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | Edwards Lifesciences | 12/18/2025SE |
| K253141 | DeepRhythmAIDQK · Traditional | Medicalgorithmics S.A. | 12/11/2025SE |
| K252429 | Vektor Computational ECG Mapping System (vMap®)DQK · Traditional | Vektor Medical, Inc. | 12/04/2025SE |
| K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubDQK · Abbreviated | Philips Medical Systems Nederland B.V. | 10/24/2025SE |
| K252238 | CoroFlow Cardiovascular SystemDQK · Traditional | Coroventis Research AB | 10/24/2025SE |
| K253034 | HemoSphere Stream ModuleDQK · Special | Edwards Lifesciences | 10/21/2025SE |
| K252013 | EnSite X EP SystemDQK · Traditional | Abbott Medical | 09/25/2025SE |
| K251518 | Volta AF-Xplorer IIDQK · Traditional | Volta Medical | 09/12/2025SE |
| K251463 | EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP…DQK · Special | Abbott Medical | 09/04/2025SE |
| K252302 | CARTO 3 EP Navigation System V8.1DQK · Special | Biosense Webster, Inc. | 08/22/2025SE |
| K251234 | EnSite X EP SystemDQK · Traditional | Abbott Medical | 07/30/2025SE |
| K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…DQK · Traditional | Edwards Lifesciences | 07/23/2025SE |
| K250747 | Globe® Pulsed Field SystemDQK · Traditional | Kardium, Inc. | 06/25/2025SE |
| K250749 | PhysCade SystemDQK · Traditional | Physcade, Inc. | 06/04/2025SE |
| K251344 | OptiMap SystemDQK · Special | Boston Scientific Corporation | 05/28/2025SE |
| K250932 | DeepRhythmAIDQK · Traditional | Medicalgorithmics S.A. | 05/27/2025SE |
| K243812 | Volta AF-XplorerDQK · Traditional | Volta Medical | 05/09/2025SE |
| K242129 | VitalRhythmDQK · Traditional | Vitalconnect, Inc. | 04/17/2025SE |
| K243842 | Intra-Operative Positioning System (IOPS®)DQK · Traditional | Centerline Biomedical, Inc. | 03/06/2025SE |
| K243312 | Cer-SDQK · Traditional | Cardiocalm Srl | 02/20/2025SE |
| K243892 | Affera Integrated Mapping SystemDQK · Special | Medtronic, Inc. | 01/17/2025SE |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…DQK · Special | Ge Medical Systems Information Technologies, Inc. | 12/12/2024SE |
| K243435 | Magnetic Localization Patch Kit (AFR-00021)DQK · Special | Medtronic, Inc. | 12/05/2024SE |
| K241197 | DeepRhythmAIDQK · Traditional | Medicalgorithmics S.A. | 12/04/2024SE |
| K241828 | Affera Integrated Mapping System; Impedance Localization Patch KitDQK · Traditional | Medtronic, Inc. | 11/01/2024SE |
| K242133 | Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…DQK · Special | Centerline Biomedical, Inc. | 10/11/2024SE |
| K241227 | RHYTHMIA HDx Mapping SystemDQK · Traditional | Boston Scientific Corporation | 08/29/2024SE |
| K233755 | HeartKey® RhythmDQK · Traditional | B-Secur Limited | 08/16/2024SE |
| K242016 | EnSite X EP SystemDQK · Special | Abbott Medical | 08/09/2024SE |
| K240509 | STAR Apollo Mapping SystemDQK · Traditional | Rhythm AI, Ltd. | 07/26/2024SE |
| K241243 | Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…DQK · Special | Centerline Biomedical, Inc. | 07/24/2024SE |
| K233326 | Merge Hemo, Model RCSV2DQK · Traditional | Merge Healthcare Incorporated | 06/21/2024SE |
| K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubDQK · Special | Philips Medical Systems Nederland B.V. | 03/14/2024SE |
| K233943 | Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart…DQK · Traditional | Medtronic, Inc. | 03/08/2024SE |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK · Traditional | Ge Medical Systems Information Technologies, Inc. | 12/13/2023SE |
| K233160 | NeuTrace EP Mapping System v.2.1DQK · Traditional | Anumana, Inc. | 11/25/2023SE |
| K232294 | HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart…DQK · Traditional | Edwards Lifesciences, LLC | 10/31/2023SE |
| K232616 | Volta AF-XplorerDQK · Special | Volta Medical | 09/27/2023SE |
| K230884 | AVVIGO'+ Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific Corporation | 09/26/2023SE |
| K223812 | Sensis Vibe (VD15)DQK · Traditional | Siemens Medical Solutions USA, Inc. | 09/15/2023SE |
| K231207 | CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK · Traditional | Biosense Webster, Inc. | 09/07/2023SE |
| K230579 | Smart Wedge algorithmDQK · Traditional | Edwards Lifesciences, LLC | 08/18/2023SE |
| K231415 | EnSite X EP SystemDQK · Traditional | Abbott Medical | 08/10/2023SE |
| K223787 | ECGenius SystemDQK · Traditional | Cath Vision Aps | 08/04/2023SE |
| K231620 | Nuubo SmartDQK · Traditional | Smart Solutions Technologies SL | 08/01/2023SE |
| K231035 | FusedCO AlgorithmDQK · Traditional | Edwards Lifesciences, LLC | 07/12/2023SE |
| K231091 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 07/10/2023SE |
| K230309 | Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…DQK · Special | Centerline Biomedical, Inc. | 06/21/2023SE |
| K223865 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid…DQK · Traditional | Edwards Lifesciences, LLC | 06/09/2023SE |
| K230008 | Ablamap® SystemDQK · Traditional | Ablacon, Inc. | 06/08/2023SE |
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubDQK · Abbreviated | Philips Medical Systems Nederland B.V. | 06/08/2023SE |
| K230606 | AcQMap® High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 05/02/2023SE |
| K223733 | CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4DQK · Traditional | Biosense Webster, Inc. | 02/16/2023SE |
| K222389 | ZEUS SystemDQK · Traditional | iRhythm Technologies, Inc. | 02/15/2023SE |
| K223516 | VX1+DQK · Traditional | Volta Medical | 01/21/2023SE |
| K211557 | EndoPATxDQK · Traditional | Itamar Medical , Ltd. | 12/29/2022SE |
| K223094 | EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade…DQK · Traditional | Abbott Medical | 12/27/2022SE |
| K220786 | STAR Apollo Mapping SystemDQK · Traditional | Rhythm Al, Ltd. | 12/01/2022SE |
| K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion…DQK · Traditional | Edwards Lifesciences, LLC | 11/22/2022SE |
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableDQK · Special | Edwards Lifeciences, LLC | 11/07/2022SE |
| K212493 | KODEX EPD System 1.5.0DQK · Traditional | Philips Medical Systems Nederland, B.V. (Pmsn) | 10/24/2022SE |
| K222209 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 10/17/2022SE |
| K221213 | EnSite X EP SystemDQK · Traditional | Abbott | 08/18/2022SE |
| K221112 | CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK · Traditional | Biosense Webster, Inc. | 08/17/2022SE |
| K210822 | DeepRhythmAIDQK · Traditional | Medicalgorithmics S.A. | 07/27/2022SE |
| K213409 | ZEUS System (Zio Watch)DQK · Traditional | iRhythm Technologies, Inc. | 07/19/2022SE |
| K220784 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 07/01/2022SE |
| K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable…DQK · Traditional | Edwards Lifesciences, LLC | 06/22/2022SE |
| K220306 | ECGenius SystemDQK · Traditional | Cath Vision Aps | 05/03/2022SE |
| K220243 | Ultiri Measurement SystemDQK · Traditional | Abbott Medical | 04/30/2022SE |
| K212662 | AliveCor QT ServiceDQK · Traditional | AliveCor, Inc. | 04/26/2022SE |
| K213861 | Cer-SDQK · Traditional | Cardiocalm Srl | 04/25/2022SE |
| K213972 | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording…DQK · Traditional | Ge Healthcare Information Technologies, Inc. | 02/17/2022SE |
| K202094 | Cardiovascular Suite 4.2.1DQK · Traditional | Quipu S.R.L | 01/11/2022SE |
| K213364 | EnSite X EP SystemDQK · Special | Abbott Medical | 11/11/2021SE |
| K211546 | Vektor Computational ECG Mapping System (vMap)DQK · Traditional | Vektor Medical, Inc. | 11/09/2021SE |
| K210543 | IM007DQK · Traditional | Implicity, Inc. | 11/03/2021SE |
| K213264 | CARTO 3 EP Navigation System Version 7.2DQK · Special | Biosense Webster, Inc. | 10/29/2021SE |
| K212061 | EnSite X EP SystemDQK · Traditional | Abbott | 10/22/2021SE |
| K212490 | AVVIGO Guidance System IIDQK · Special | Boston Scientific Corporation | 10/20/2021SE |
| K203084 | Ablamap SoftwareDQK · Traditional | Ablacon, Inc. | 08/31/2021SE |
| K212345 | AcQMap High Resolution Imaging and Mapping SystemDQK · Special | Acutus Medical, Inc. | 08/27/2021SE |
| K201094 | iMap 3D Mapping & Navigation System (iMap System)DQK · Traditional | Cardionxt, Inc. | 08/16/2021SE |
| K210680 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 08/05/2021SE |
| K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring PlatformDQK · Traditional | Edwards Lfesciences | 07/08/2021SE |
| K210889 | iLab Polaris Multi-Modality Guidance SystemDQK · Special | Boston Scientific Corporation | 06/25/2021SE |
| K203687 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction…DQK · Traditional | Edwards Lifesciences, LLC | 05/28/2021SE |
| K202527 | Zio ECG Utilization Software (ZEUS) SystemDQK · Traditional | iRhythm Technologies, Inc. | 05/21/2021SE |
| K201921 | Spacelabs Lifescreen PRO AnalyzerDQK · Traditional | Spacelabs Healthcare, Ltd. | 03/26/2021SE |
| K210392 | WorkMate Claris SystemDQK · Special | Abbott | 03/11/2021SE |
| K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterDQK · Traditional | Philips Medical System Nederland B.V. | 12/17/2020SE |
| K202189 | GraffitiDQK · Traditional | Ge Medical Systems Information Technologies, Inc. | 12/08/2020SE |
| K201015 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 12/01/2020SE |
| K202066 | EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL…DQK · Traditional | Abbott Medical | 11/25/2020SE |
| K200484 | CARTO® 3 EP Navigation System with Signal Processing UnitDQK · Traditional | Biosense Webster, Inc. | 11/25/2020SE |
| K201060 | Cordiana Dx16DQK · Traditional | Cordiana Medical Informatics AG | 11/16/2020SE |
| K201881 | CoroFlow Cardiovascular SystemDQK · Traditional | Coroventis Research AB | 11/13/2020SE |
| K201985 | KardiaAIDQK · Traditional | AliveCor, Inc. | 11/12/2020SE |
| K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight ModuleDQK · Traditional | Edwards Lifesiences, LLC | 10/01/2020SE |
| K201298 | VX1DQK · Traditional | Volta Medical | 09/16/2020SE |
| K200313 | VivoDQK · Traditional | Catheter Precision, Inc. | 09/14/2020SE |
| K201713 | AVVIGO Guidance SystemDQK · Special | Boston Scientific Corporation | 07/23/2020SE |
| K201181 | EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping SystemDQK · Traditional | Abbott Medical | 06/26/2020SE |
| K201148 | EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation…DQK · Traditional | Abbott Medical | 06/26/2020SE |
| K201178 | iLab Polaris Multi-Modality Guidance SystemDQK · Special | Boston Scientific | 05/29/2020SE |
| K193013 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 02/11/2020SE |
| K192438 | Rhythmia HDxTM Mapping SystemDQK · Traditional | Boston Scientific Corporation | 11/27/2019SE |
| K191392 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 09/06/2019SE |
| K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleDQK · Traditional | Edwards Lifesciences, LLC | 08/29/2019SE |
| K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemDQK · Traditional | iRhythm Technologies, Inc. | 08/23/2019SE |
| K191660 | CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK · Special | Biosense Webster, Inc. | 07/20/2019SE |
| K191008 | iLab Polaris Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific Corporation | 07/02/2019SE |
| K190106 | Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…DQK · Traditional | Centerline Biomedical, Inc. | 06/24/2019SE |
| K183195 | VivoDQK · Traditional | Catheter Precision, Inc. | 06/14/2019SE |
| K191089 | Edwards Pressure CableDQK · Traditional | Edwards Lifesciences, LLC | 06/13/2019SE |
| K190131 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 04/02/2019SE |
| K181823 | KardiaAIDQK · Traditional | AliveCor, Inc. | 03/11/2019SE |
| K182344 | RhythmAnalyticsDQK · Traditional | Biofourmis Singapore Pte., Ltd. | 03/07/2019SE |
| K183266 | EP-TRACER SystemDQK · Special | Schwarzer Cardiotek GmbH | 03/01/2019SE |
| K183099 | QUANTIEN Measurement SystemDQK · Traditional | St. Jude Medical (Now Abbott Medical) | 02/28/2019SE |
| K181577 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 02/07/2019SE |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQK · Special | Abbott | 12/12/2018SE |
| K180432 | AI-ECG PlatformDQK · Traditional | Shenzhen Carewell Electronics., Ltd. | 11/19/2018SE |
| K180881 | HemoSphere Advanced Monitor, HemoSphere Pressure CableDQK · Traditional | Edwards Lifesciences, LLC | 11/16/2018SE |
| K181918 | CardioInsight Cardiac Mapping SystemDQK · Traditional | Medtronic, Inc. | 11/08/2018SE |
| K180940 | KODEX EPD SystemDQK · Traditional | Philips Medical Systems Nederland B.V. | 10/24/2018SE |
| K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQK · Special | Abbott | 10/19/2018SE |
| K181502 | Zio AT ECG Monitoring System, ZEUS SystemDQK · Traditional | iRhythm Technologies, Inc. | 08/29/2018SE |
| K173978 | CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER ModuleDQK · Traditional | Biosense Webster, Inc. | 08/24/2018SE |
| K180805 | Pure EPDQK · Traditional | Biosig Technologies | 08/08/2018SE |
| K181720 | Epiphany Cardio Server MobileDQK · Traditional | Epiphany Healthcare, LLC | 07/30/2018SE |
| K173837 | RHYTHMIA HDx Mapping System (with software Version 2.0)DQK · Traditional | Boston Scientific Corporation | 07/25/2018SE |
| K173977 | CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP ModuleDQK · Traditional | Biosense Webster, Inc. | 06/14/2018SE |
| K180238 | CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTDQK · Traditional | Biosense Webster, Inc. | 06/01/2018SE |
| K172396 | EnSite Velocity Cardiac Mapping System v5.2DQK · Traditional | St Jude Medical | 04/23/2018SE |
| K170948 | AcQMap High Resolution Imaging and Mapping SystemDQK · Traditional | Acutus Medical, Inc. | 10/16/2017SE |
| K171583 | RhythmView WorkstationDQK · Traditional | Abbott Electrophysiology | 09/01/2017SE |
| K172182 | QUANTIEN Measurement SystemDQK · Special | St. Jude Medical (Now Part of the Abbott Medical) | 08/18/2017SE |
| K170600 | CARTO 3 EP Navigation System, Version 6.0 and AccessoriesDQK · Traditional | Biosense Webster, Inc. | 07/25/2017SE |
| K163381 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry CableDQK · Traditional | Edwards Lifesciences, LLC | 04/14/2017SE |
| K162023 | CardioDay V2.5DQK · Traditional | Getemed Medizin- Und Informationstechnik AG | 03/24/2017SE |
| K162793 | RHYTHMIA HDx Mapping SystemDQK · Traditional | Boston Scientific Corporation | 03/10/2017SE |
| K162643 | MediGuide Technology SystemDQK · Traditional | St Jude Medical | 12/13/2016SE |
| K160218 | AutoMark ModuleDQK · Traditional | St Jude Medical | 12/13/2016SE |
| K160210 | EnSite Precision Cardiac Mapping System v2.0DQK · Traditional | St Jude Medical | 12/13/2016SE |
| K162440 | CardioInsight Cardiac Mapping SystemDQK · Special | Cardioinsight Technologies, Inc. | 11/04/2016SE |
| K160187 | Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0DQK · Traditional | St Jude Medical | 10/21/2016SE |
| K160186 | EnSite Velocity Surface Electrode KitDQK · Traditional | St Jude Medical | 10/07/2016SE |
| K153654 | Sentry WEB SmartInterpDQK · Traditional | Carefusion Germany 234 GmbH | 09/16/2016SE |
| K161465 | CardioConfirmDQK · Traditional | Mortara Instrument, Inc. | 09/03/2016SE |
| K161240 | Rhythm View Workstation (non-streaming)DQK · Traditional | Abbott Electrophysiology | 08/10/2016SE |
| K161245 | EP-TRACER SystemDQK · Traditional | Cardio Tek, BV | 08/05/2016SE |
| K152864 | Merge HemoDQK · Traditional | Merge Healthcare Incorporated | 04/07/2016SE |
| K152881 | Sentinel Cardiology Information Management SystemDQK · Traditional | Spacelabs Healthcare, Ltd. | 04/01/2016SE |
| K152160 | Navik 3DDQK · Traditional | Apn Health, LLC | 02/23/2016SE |
| K151787 | Holter SystemDQK · Traditional | Edan Instruments, Inc. | 01/27/2016SE |
| K152993 | MUSE Cardiology Information SystemDQK · Special | Ge Medical Systems Information Technologies, Inc. | 01/12/2016SE |
| K151911 | WorkMate Claris System, WorkMate Claris System Display PlusDQK · Traditional | St Jude Medical | 10/22/2015SE |
| K151613 | iLab Polaris Multi-Modality Guidance SystemDQK · Traditional | Boston Scientific Corporation | 10/06/2015SE |
| K142349 | TM eCloud ECG Analysis SystemDQK · Traditional | Telemed Solutions, Inc. | 09/21/2015SE |
| K151245 | Rhythm View Workstation (non-streaming, steaming option)DQK · Traditional | Topera, Inc. | 09/15/2015SE |
| K150990 | ECVUE Mapping SystemDQK · Special | Cardioinsight Technologies, Inc. | 07/02/2015SE |
| K150493 | SensisDQK · Traditional | Siemens Medi Cal Solutions, Inc. | 06/30/2015SE |
| K143449 | ADH 200 Analyzer SoftwareDQK · Traditional | Adams Meditech, LLC | 06/26/2015SE |
| K142901 | RhythmView WorkstationDQK · Special | Topera, Inc. | 12/19/2014SE |
| K142681 | ZEUS (ZIO ECG Utilization Service) SystemDQK · Special | iRhythm Technologies, Inc. | 11/21/2014SE |
| K140497 | Ecvue Mapping SystemDQK · Traditional | Cardioinsight Technologies, Inc. | 11/19/2014SE |
| K133916 | Carto 3 Ep Navigation System, Version 4.2DQK · Traditional | Biosense Webster, Inc. | 07/01/2014SE |
| K141185 | V2.7 Software for the Labsystem Pro Ep Recording SystemDQK · Special | Boston Scientific Corp | 06/06/2014SE |
| K141050 | Ensite Velocity SystemDQK · Traditional | St Jude Medical | 06/06/2014SE |
| K133534 | Mckesson Cardiology ECG MobileDQK · Traditional | Mckesson Israel , Ltd. | 04/18/2014SE |
| K134044 | Ep-Tracer System, Ep-Tracer System, Ep-Tracer SystemDQK · Traditional | Cardio Tek, BV | 03/31/2014SE |
| K132782 | CARTO3 Ep Navigation System, Version 3.2DQK · Traditional | Biosense Webster, Inc. | 01/24/2014SE |
| K133305 | Rhythm View WorkstationDQK · Special | Topera, Inc. | 12/16/2013SE |
| K132437 | Mars Holter Analysis WorkstationDQK · Special | Ge Medical Systems Information Technologies, Inc. | 12/04/2013SE |
| K132073 | Ep-Workmate, Ep-Nursemate, Ep-Nursemate with Physio ModuleDQK · Special | St Jude Medical | 09/09/2013SE |
| K130727 | Ensite Velocity SystemDQK · Traditional | St Jude Medical | 08/29/2013SE |
| K130516 | CardiodayDQK · Traditional | Getemed Medizin- Und Informationstechnik AG | 08/23/2013SE |
| K131812 | Sensis, Sensis LiteDQK · Special | Siemens Medi Cal Solutions, Inc. | 07/25/2013SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3143-2026 | Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13…Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to… | GE Medical Systems Information Technologies… | 07/30/2026Open, Classified |
| Z-2279-2026 Class II | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3Electrical sparking may occur at the printer head. If the Electrostatic Discharge (ESD) printer brush… | GE Medical Systems Information Technologies… | 04/24/2026Open, Classified |
| Z-0416-2026 Class II | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software…Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of… | Spacelabs Healthcare, Ltd. | 09/16/2025Open, Classified |
| Z-2518-2025 Class II | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and…Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS… | Merge Healthcare, Inc. | 08/11/2025Open, Classified |
| Z-1760-2025 Class I | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate…Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate… | Centerline Biomedical Inc | 04/11/2025Open, Classified |
| Z-0116-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0115-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0114-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0113-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0112-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0111-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0110-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0109-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0108-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0107-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0106-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU +…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0105-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL -…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0104-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0103-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0102-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0101-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0100-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0099-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0098-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0097-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0096-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0095-2025 Class II | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED…Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not… | Boston Scientific Corporation | 09/05/2024Open, Classified |
| Z-0128-2025 Class II | McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can… | Change Healthcare Canada Company | 08/21/2024Open, Classified |
| Z-0127-2025 Class II | Horizon Cardiology Hemo. Version 12.2.A potential issue has been identified in Change Healthcare Cardiology Hemo where incorrect data entry can… | Change Healthcare Canada Company | 08/21/2024Open, Classified |
| Z-2441-2024 Class II | Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | Siemens Medical Solutions USA, Inc | 07/03/2024Open, Classified |
| Z-2440-2024 Class II | Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | Siemens Medical Solutions USA, Inc | 07/03/2024Open, Classified |
| Z-2439-2024 Class II | Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | Siemens Medical Solutions USA, Inc | 07/03/2024Open, Classified |
| Z-2438-2024 Class II | Sensis Vibe systems with software version VD15B in combination with Sensis High End…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | Siemens Medical Solutions USA, Inc | 07/03/2024Open, Classified |
| Z-2258-2024 Class II | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording…Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resulting in… | GE Medical Systems Information Technologies… | 04/22/2024Open, Classified |
| Z-0683-2024 Class II | Sensis Vibe HemoThe possibility of the Sensis documentation functionality application to crash. | Siemens Medical Solutions USA, Inc | 11/29/2023Open, Classified |
| Z-0556-2024 Class III | Navik 3D v2, REF NAVIK3D, 3D Mapping SystemIFU update | APN Health LLC | 11/07/2023Open, Classified |
| Z-2647-2023 Class II | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions:…Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio… | Baxter Healthcare Corporation | 08/10/2023Open, Classified |
| Z-2613-2023 Class II | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569…A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach… | GE Medical Systems Information Technologies… | 08/08/2023Open, Classified |
| Z-0775-2023 Class II | Programmable Diagnostic ComputerThe firm will be performing a software update to address a software error which affects the listed products.… | Siemens Medical Solutions USA, Inc | 11/16/2022Open, Classified |
| Z-1558-2022 Class III | AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis…The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility… | Siemens Medical Solutions USA, Inc | 07/12/2022Terminated |
| Z-1426-2022 Class II | Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool…Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the… | Siemens Medical Solutions USA, Inc | 06/15/2022Open, Classified |
| Z-1425-2022 Class II | Sensis with software version VD12A. A diagnostic and administrative tool supporting…Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the… | Siemens Medical Solutions USA, Inc | 06/15/2022Open, Classified |
| Z-1283-2022 Class II | CardioTek EP-TRACER Software V2.x.Device did not pass electrical safety testing for adequate insulation. | CardioTek BV | 04/25/2022Completed |
| Z-1243-2022 Class II | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153…Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite… | Siemens Medical Solutions USA, Inc | 04/13/2022Open, Classified |
| Z-0919-2022 Class II | MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c)…Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in… | GE Healthcare, LLC | 03/16/2022Terminated |
| Z-0499-2022 Class II | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material #…Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version… | Siemens Medical Solutions USA, Inc | 11/23/2021Open, Classified |
| Z-2387-2021 Class II | Merge Hemo, Software packages 10.2, 10.3, and 10.4The firm identified a safety issue affecting the software associated with Merge Hemo versions 9.x and 10.x… | Merge Healthcare, Inc. | 07/23/2021Terminated |
| Z-1855-2021 Class II | WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012Due to a software error, the user may lose functionality of the system or the screen may turn black during… | Abbott Laboratories Inc. (St Jude Medical) | 05/05/2021Terminated |
| Z-1854-2021 Class II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model…Due to a software error, the user may lose functionality of the system or the screen may turn black during… | Abbott Laboratories Inc. (St Jude Medical) | 05/05/2021Terminated |
| Z-1853-2021 Class II | v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123.…Due to a software error, the user may lose functionality of the system or the screen may turn black during… | Abbott Laboratories Inc. (St Jude Medical) | 05/05/2021Terminated |