ClearanceBrief
Panels › Cardiovascular › Product code DQK · Class 2

Computer, Diagnostic, Programmable

Regulation 870.1425

29510(k)s in 12 months (442 all time)
2recalls in 12 months (125 all time)
121recalls that name a 510(k)
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Top companies in DQK

Company510(k)sRecalls
Biosense Webster, Inc.347
Boston Scientific1524
Siemens Medical Solutions USA, Inc.525
St Jude Medical231
Ge Medical Systems Information Technologies185
Edwards Lifesciences152
Merge Healthcare Incorporated215
ABBOTT MEDICAL140
Acutus Medical, Inc.120
Spacelabs Healthcare48
Decided510(k)Device and applicantCode
Nov 8, 2018K181918CardioInsight Cardiac Mapping System
Medtronic, Inc.
DQK
Oct 24, 2018K180940KODEX EPD System
Philips Medical Systems Nederland B.V., NL
DQK
Oct 19, 2018K182644EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott
DQK
Aug 29, 2018K181502Zio AT ECG Monitoring System, ZEUS System
iRhythm Technologies, Inc.
DQK
Aug 24, 2018K173978CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module
Biosense Webster, Inc.
DQK
Aug 8, 2018K180805Pure EP
Biosig Technologies
DQK
Jul 30, 2018K181720Epiphany Cardio Server Mobile
Epiphany Healthcare, LLC
DQK
Jul 25, 2018K173837RHYTHMIA HDx Mapping System (with software Version 2.0)
Boston Scientific Corporation
DQK
Jun 14, 2018K173977CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
Biosense Webster, Inc.
DQK
Jun 1, 2018K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
Biosense Webster, Inc.
DQK
Apr 23, 2018K172396EnSite Velocity Cardiac Mapping System v5.2
St Jude Medical
DQK
Oct 16, 2017K170948AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Sep 1, 2017K171583RhythmView Workstation
Abbott Electrophysiology
DQK
Aug 18, 2017K172182QUANTIEN Measurement System
St. Jude Medical (Now Part of the Abbott Medical)
DQK
Jul 25, 2017K170600CARTO 3 EP Navigation System, Version 6.0 and Accessories
Biosense Webster, Inc.
DQK
Apr 14, 2017K163381HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Edwards Lifesciences, LLC
DQK
Mar 24, 2017K162023CardioDay V2.5
Getemed Medizin- Und Informationstechnik AG, DE
DQK
Mar 10, 2017K162793RHYTHMIA HDx Mapping System
Boston Scientific Corporation
DQK
Dec 13, 2016K162643MediGuide Technology System
St Jude Medical
DQK
Dec 13, 2016K160218AutoMark Module
St Jude Medical
DQK
Dec 13, 2016K160210EnSite Precision Cardiac Mapping System v2.0
St Jude Medical
DQK
Nov 4, 2016K162440CardioInsight Cardiac Mapping System
Cardioinsight Technologies, Inc.
DQK
Oct 21, 2016K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
St Jude Medical
DQK
Oct 7, 2016K160186EnSite Velocity Surface Electrode Kit
St Jude Medical
DQK
Sep 16, 2016K153654Sentry WEB SmartInterp
Carefusion Germany 234 GmbH, DE
DQK
Sep 3, 2016K161465CardioConfirm
Mortara Instrument, Inc.
DQK
Aug 10, 2016K161240Rhythm View Workstation (non-streaming)
Abbott Electrophysiology
DQK
Aug 5, 2016K161245EP-TRACER System
Cardio Tek, BV, NL
DQK
Apr 7, 2016K152864Merge Hemo
Merge Healthcare Incorporated
DQK
Apr 1, 2016K152881SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM
Spacelabs Healthcare, Ltd., GB
DQK
Feb 23, 2016K152160Navik 3D
Apn Health, LLC
DQK
Jan 27, 2016K151787Holter System
Edan Instruments, Inc., CN
DQK
Jan 12, 2016K152993MUSE Cardiology Information System
Ge Medical Systems Information Technologies, Inc.
DQK
Oct 22, 2015K151911WorkMate Claris System, WorkMate Claris System Display Plus
St Jude Medical
DQK
Oct 6, 2015K151613iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation
DQK
Sep 21, 2015K142349TM eCloud ECG Analysis System
Telemed Solutions, Inc.
DQK
Sep 15, 2015K151245Rhythm View Workstation (non-streaming, steaming option)
Topera, Inc.
DQK
Jul 2, 2015K150990ECVUE Mapping System
Cardioinsight Technologies, Inc.
DQK
Jun 30, 2015K150493Sensis
Siemens Medi Cal Solutions, Inc.
DQK
Jun 26, 2015K143449ADH 200 Analyzer Software
Adams Meditech, LLC
DQK
Dec 19, 2014K142901RhythmView Workstation
Topera, Inc.
DQK
Nov 21, 2014K142681ZEUS (ZIO ECG Utilization Service) System
iRhythm Technologies, Inc.
DQK
Nov 19, 2014K140497ECVUE MAPPING SYSTEM
Cardioinsight Technologies, Inc.
DQK
Jul 1, 2014K133916CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
Biosense Webster, Inc.
DQK
Jun 6, 2014K141185V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
Boston Scientific Corp
DQK
Jun 6, 2014K141050ENSITE VELOCITY SYSTEM
St Jude Medical
DQK
Apr 18, 2014K133534MCKESSON CARDIOLOGY ECG MOBILE
Mckesson Israel , Ltd.
DQK
Mar 31, 2014K134044EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM
Cardio Tek, BV
DQK
Jan 24, 2014K132782CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
Biosense Webster, Inc.
DQK
Dec 16, 2013K133305RHYTHM VIEW WORKSTATION
Topera, Inc.
DQK

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