ClearanceBrief
Panels › Cardiovascular › Product code DQK · Class 2

Computer, Diagnostic, Programmable

Regulation 870.1425

27510(k)s in 12 months (440 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
Oct 23, 2026K263380STAR Apollo™ Mapping System
Rhythm AI, Ltd., GB
DQK
Oct 1, 2026K263016Intra-Operative Positioning System (IOPS) and IOPS Visionary System
Centerline Biomedical
DQK
Sep 17, 2026K261729EnSite™ X EP System
Abbott Medical
DQK
Aug 21, 2026K262005Affera Integrated Mapping System
Medtronic, Inc.
DQK
Aug 21, 2026K253692AVVIGO™+ Multi-Modality Guidance System
Boston Scientific
DQK
Jul 26, 2026K253576CorVista System® with PCWP Add-On
Analytics For Life, Inc.
DQK
Jul 15, 2026K262006EnSite™ X EP System
Abbott Medical
DQK
Jul 9, 2026K252978ScioCardio ECG Analysis Platform
Synergen Technology Labs, LLC
DQK
Jul 2, 2026K253463ILR ECG Analyzer (IM007)
Implicity, Inc.
DQK
Jun 30, 2026K261119NorthStar Mapping System (MAP01 or MAP01-01)
Imricor Medical Systems, Inc.
DQK
Jun 12, 2026K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)
Micropace Pty, Ltd., AU
DQK
Jun 10, 2026K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simp
Centerline Biomedical
DQK
May 29, 2026K252859ZEUS Platform (FG0501US)
iRhythm Technologies, Inc.
DQK
Apr 20, 2026K260212EnSite™ X EP System
ABBOTT MEDICAL
DQK
Apr 13, 2026K253861ACORYS MAPPING SYSTEM
Corify Care S.L, ES
DQK
Apr 1, 2026K253473Synchrony
Stereotaxis, Inc.
DQK
Feb 24, 2026K253186HemoSphere Nano Monitor (HSNANO1)
Edwards Lifesciences, LLC
DQK
Feb 20, 2026K252972CARTO™ 3 EP Navigation System V8.4
Biosense Webster, Inc.
DQK
Feb 17, 2026K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter,
Centerline Biomedical, Inc.
DQK
Feb 9, 2026K251591Holter ECG and ABP system (HolterABP)
Edan Instruments, Inc., CN
DQK
Feb 6, 2026K251218SafeBeat Rx App
SafeBeat Rx, Inc.
DQK
Jan 28, 2026K252164NorthStar™ Mapping System
Imricor Medical Systems
DQK
Jan 18, 2026K254085CARTO™ 3 EP Navigation System V9.0 with PIU Plus
Biosense Webster, Inc.
DQK
Dec 19, 2025K253733STAR Apollo™ Mapping System
Rhythm AI, Ltd., GB
DQK
Dec 18, 2025K252533HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
Edwards Lifesciences
DQK
Dec 11, 2025K253141DeepRhythmAI
Medicalgorithmics S.A., PL
DQK
Dec 4, 2025K252429Vektor Computational ECG Mapping System (vMap®)
Vektor Medical, Inc.
DQK
Oct 24, 2025K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
Philips Medical Systems Nederland B.V., NL
DQK
Oct 24, 2025K252238CoroFlow Cardiovascular System
Coroventis Research AB, SE
DQK
Oct 21, 2025K253034HemoSphere Stream Module
Edwards Lifesciences
DQK
Sep 25, 2025K252013EnSite™ X EP System
ABBOTT MEDICAL
DQK
Sep 12, 2025K251518Volta AF-Xplorer II
Volta Medical, FR
DQK
Sep 4, 2025K251463EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Soft
ABBOTT MEDICAL
DQK
Aug 22, 2025K252302CARTO™ 3 EP Navigation System V8.1
Biosense Webster, Inc.
DQK
Jul 30, 2025K251234EnSite™ X EP System
ABBOTT MEDICAL
DQK
Jul 23, 2025K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Sm
Edwards Lifesciences
DQK
Jun 25, 2025K250747Globe® Pulsed Field System
Kardium, Inc., CA
DQK
Jun 4, 2025K250749PhysCade System
Physcade, Inc.
DQK
May 28, 2025K251344OptiMap™ System
Boston Scientific Corporation
DQK
May 27, 2025K250932DeepRhythmAI
Medicalgorithmics S.A., PL
DQK
May 9, 2025K243812Volta AF-Xplorer
Volta Medical, FR
DQK
Apr 17, 2025K242129VitalRhythm
Vitalconnect, Inc.
DQK
Mar 6, 2025K243842Intra-Operative Positioning System (IOPS®)
Centerline Biomedical, Inc.
DQK
Feb 20, 2025K243312CER-S
Cardiocalm Srl, IT
DQK
Jan 17, 2025K243892Affera Integrated Mapping System
Medtronic, Inc.
DQK
Dec 12, 2024K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
Ge Medical Systems Information Technologies, Inc.
DQK
Dec 5, 2024K243435Magnetic Localization Patch Kit (AFR-00021)
Medtronic, Inc.
DQK
Dec 4, 2024K241197DeepRhythmAI
Medicalgorithmics S.A., PL
DQK
Nov 1, 2024K241828Affera Integrated Mapping System; Impedance Localization Patch Kit
Medtronic, Inc.
DQK
Oct 11, 2024K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewir
Centerline Biomedical, Inc.
DQK

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