Computer, Diagnostic, Programmable

DQK 2021-10-20

AVVIGO Guidance System II

K number K212490

DQK 2021-08-31

Ablamap Software

Applicant Ablacon, Inc.

K number K203084

DQK 2021-08-27

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K212345

DQK 2021-08-16

iMap 3D Mapping & Navigation System (iMap System)

Applicant Cardionxt, Inc.

K number K201094

DQK 2021-08-05

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K210680

DQK 2021-07-08

HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

Applicant Edwards Lfesciences

K number K211465

DQK 2021-06-25

iLab Polaris Multi-Modality Guidance System

K number K210889

DQK 2021-05-28

HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

K number K203687

DQK 2021-05-21

Zio ECG Utilization Software (ZEUS) System

Applicant iRhythm Technologies, Inc.

K number K202527

DQK 2021-03-26

Spacelabs Lifescreen PRO Analyzer

Applicant Spacelabs Healthcare, Ltd.

K number K201921

DQK 2021-03-11

WorkMate Claris System

Applicant Abbott

K number K210392

DQK 2020-12-17

AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter

Applicant Philips Medical System Nederland B.V.

K number K201081

DQK 2020-12-08

Graffiti

Applicant Ge Medical Systems Information Technologies, Inc.

K number K202189

DQK 2020-12-01

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K201015

DQK 2020-11-25

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

Applicant ABBOTT MEDICAL

K number K202066

DQK 2020-11-25

CARTO® 3 EP Navigation System with Signal Processing Unit

Applicant Biosense Webster, Inc.

K number K200484

DQK 2020-11-16

Cordiana Dx16

Applicant Cordiana Medical Informatics AG

K number K201060

DQK 2020-11-13

CoroFlow Cardiovascular System

Applicant Coroventis Research AB

K number K201881

DQK 2020-11-12

KardiaAI

Applicant AliveCor, Inc.

K number K201985

DQK 2020-10-01

HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

Applicant Edwards Lifesiences, LLC

K number K201446

DQK 2020-09-16

VX1

Applicant Volta Medical

K number K201298

DQK 2020-09-14

VIVO

Applicant Catheter Precision, Inc.

K number K200313

DQK 2020-07-23

AVVIGO Guidance System

K number K201713

DQK 2020-06-26

EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System

Applicant ABBOTT MEDICAL

K number K201181

DQK 2020-06-26

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

Applicant ABBOTT MEDICAL

K number K201148

DQK 2020-05-29

iLab Polaris Multi-Modality Guidance System

Applicant Boston Scientific

K number K201178

DQK 2020-02-11

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K193013

DQK 2019-11-27

Rhythmia HDxTM Mapping System

K number K192438

DQK 2019-09-06

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K191392

DQK 2019-08-29

HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module

K number K190205

DQK 2019-08-23

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

Applicant iRhythm Technologies, Inc.

K number K190593

DQK 2019-07-20

CARTO 3 EP Navigation System, Version 7.1 and Accessories

Applicant Biosense Webster, Inc.

K number K191660

DQK 2019-07-02

iLab Polaris Multi-Modality Guidance System

K number K191008

DQK 2019-06-24

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

Applicant Centerline Biomedical, Inc.

K number K190106

DQK 2019-06-14

VIVO

Applicant Catheter Precision, Inc.

K number K183195

DQK 2019-06-13

Edwards Pressure Cable

K number K191089

DQK 2019-04-02

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K190131

DQK 2019-03-11

KardiaAI

Applicant AliveCor, Inc.

K number K181823

DQK 2019-03-07

RhythmAnalytics

Applicant Biofourmis Singapore Pte., Ltd.

K number K182344

DQK 2019-03-01

EP-TRACER System

Applicant Schwarzer Cardiotek GmbH

K number K183266

DQK 2019-02-28

QUANTIEN Measurement System

Applicant St. Jude Medical (Now Abbott Medical)

K number K183099

DQK 2019-02-07

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K181577

DQK 2018-12-12

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Applicant Abbott

K number K183128

DQK 2018-11-19

AI-ECG Platform

Applicant Shenzhen Carewell Electronics., Ltd.

K number K180432

DQK 2018-11-16

HemoSphere Advanced Monitor, HemoSphere Pressure Cable

K number K180881

DQK 2018-11-08

CardioInsight Cardiac Mapping System

Applicant Medtronic, Inc.

K number K181918

DQK 2018-10-24

KODEX EPD System

Applicant Philips Medical Systems Nederland B.V.

K number K180940

DQK 2018-10-19

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

Applicant Abbott

K number K182644

DQK 2018-08-29

Zio AT ECG Monitoring System, ZEUS System

Applicant iRhythm Technologies, Inc.

K number K181502

DQK 2018-08-24

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module

Applicant Biosense Webster, Inc.

K number K173978

DQK 2018-08-08

Pure EP

Applicant Biosig Technologies

K number K180805

DQK 2018-07-30

Epiphany Cardio Server Mobile

Applicant Epiphany Healthcare, LLC

K number K181720

DQK 2018-07-25

RHYTHMIA HDx Mapping System (with software Version 2.0)

K number K173837

DQK 2018-06-14

CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module

Applicant Biosense Webster, Inc.

K number K173977

DQK 2018-06-01

CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT

Applicant Biosense Webster, Inc.

K number K180238

DQK 2018-04-23

EnSite Velocity Cardiac Mapping System v5.2

Applicant St Jude Medical

K number K172396

DQK 2017-10-16

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K170948

DQK 2017-09-01

RhythmView Workstation

Applicant Abbott Electrophysiology

K number K171583

DQK 2017-08-18

QUANTIEN Measurement System

Applicant St. Jude Medical (Now Part of the Abbott Medical)

K number K172182

DQK 2017-07-25

CARTO 3 EP Navigation System, Version 6.0 and Accessories

Applicant Biosense Webster, Inc.

K number K170600

DQK 2017-04-14

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable

K number K163381

DQK 2017-03-24

CardioDay V2.5

Applicant Getemed Medizin- Und Informationstechnik AG

K number K162023

DQK 2017-03-10

RHYTHMIA HDx Mapping System

K number K162793

DQK 2016-12-13

MediGuide Technology System

Applicant St Jude Medical

K number K162643

DQK 2016-12-13

AutoMark Module

Applicant St Jude Medical

K number K160218

DQK 2016-12-13

EnSite Precision Cardiac Mapping System v2.0

Applicant St Jude Medical

K number K160210

DQK 2016-11-04

CardioInsight Cardiac Mapping System

Applicant Cardioinsight Technologies, Inc.

K number K162440

DQK 2016-10-21

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

Applicant St Jude Medical

K number K160187

DQK 2016-10-07

EnSite Velocity Surface Electrode Kit

Applicant St Jude Medical

K number K160186

DQK 2016-09-16

Sentry WEB SmartInterp

Applicant Carefusion Germany 234 GmbH

K number K153654

DQK 2016-09-03

CardioConfirm

Applicant Mortara Instrument, Inc.

K number K161465

DQK 2016-08-10

Rhythm View Workstation (non-streaming)

Applicant Abbott Electrophysiology

K number K161240

DQK 2016-08-05

EP-TRACER System

Applicant Cardio Tek, BV

K number K161245

DQK 2016-04-07

Merge Hemo

Applicant Merge Healthcare Incorporated

K number K152864

DQK 2016-04-01

SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

Applicant Spacelabs Healthcare, Ltd.

K number K152881

DQK 2016-02-23

Navik 3D

Applicant Apn Health, LLC

K number K152160

DQK 2016-01-27

Holter System

Applicant Edan Instruments, Inc.

K number K151787

DQK 2016-01-12

MUSE Cardiology Information System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K152993

DQK 2013-12-16

RHYTHM VIEW WORKSTATION

Applicant Topera, Inc.

K number K133305

DQK 2013-12-04

MARS HOLTER ANALYSIS WORKSTATION

Applicant Ge Medical Systems Information Technologies, Inc.

K number K132437

DQK 2013-09-09

EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE

Applicant St Jude Medical

K number K132073

DQK 2013-08-29

ENSITE VELOCITY SYSTEM

Applicant St Jude Medical

K number K130727

DQK 2013-08-23

CARDIODAY

Applicant Getemed Medizin- Und Informationstechnik AG

K number K130516

DQK 2013-07-25

SENSIS, SENSIS LITE

Applicant Siemens Medi Cal Solutions, Inc.

K number K131812

DQK 2013-07-22

RHYTHMIA MAPPING SYSTEM

Applicant Rhythmia Medical, Inc.

K number K130750

DQK 2013-05-29

ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE

Applicant Cardiac Designs, LLC

K number K131045

DQK 2013-05-03

ENSITE VELOCITY SYSTEM

Applicant St Jude Medical

K number K130594

DQK 2013-05-01

MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS

Applicant Ge Medical Systems Information Technologies, Inc.

K number K130626

DQK 2013-04-24

RHYTHM VIEW

Applicant Topera, Inc.

K number K123295

DQK 2013-03-28

QUANTIEN MEASUREMENT SYSTEM

Applicant Radi Medical Systems AB

K number K123984

DQK 2013-03-01

MUSE CARDIOLOGY INFORMATION SYSTEM

Applicant Ge Medical Systems Information Technologies, Inc.

K number K130155

DQK 2012-12-20

HEALTHVIEW ECG MANAGER

Applicant Lumedx

K number K123466

DQK 2012-07-18

ST80I STRESS TEST SYSTEM

Applicant Philips Health Care

K number K121638

DQK 2012-06-29

INTELLISPACE ECG

Applicant Philips Health Care

K number K120855

DQK 2012-05-07

CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

Applicant Biosense Webster, Inc.

K number K120550

DQK 2012-03-16

V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

Applicant C.R. Bard Inc., Bard Electrophysiology Division

K number K113811

DQK 2012-03-16

HORIZON CARDIOLOGY ECG MANAGEMENT

Applicant Mckesson Israel , Ltd.

K number K113515

DQK 2012-02-24

MEDIGUIDE TECHNOLOGY

Applicant St. Jude Medical, Mediguide Navigation Systems

K number K120301

DQK 2011-11-09

ENSITE VELOCITY SYSTEM V.3.0

Applicant St Jude Medical

K number K112688