Computer, Diagnostic, Programmable

DQK 2026-08-21

Affera Integrated Mapping System

Applicant Medtronic, Inc.

K number K262005

DQK 2026-08-21

AVVIGO™+ Multi-Modality Guidance System

Applicant Boston Scientific

K number K253692

DQK 2026-07-26

CorVista System® with PCWP Add-On

Applicant Analytics For Life, Inc.

K number K253576

DQK 2026-07-15

EnSite™ X EP System

Applicant Abbott Medical

K number K262006

DQK 2026-07-09

ScioCardio ECG Analysis Platform

Applicant Synergen Technology Labs, LLC

K number K252978

DQK 2026-07-02

ILR ECG Analyzer (IM007)

Applicant Implicity, Inc.

K number K253463

DQK 2026-06-30

NorthStar Mapping System (MAP01 or MAP01-01)

Applicant Imricor Medical Systems, Inc.

K number K261119

DQK 2026-06-12

OneStim-DUO Cardiac Stimulator (MP5003-4CO)

Applicant Micropace Pty, Ltd.

K number K253088

DQK 2026-06-10

Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)

Applicant Centerline Biomedical

K number K261329

DQK 2026-05-29

ZEUS Platform (FG0501US)

Applicant iRhythm Technologies, Inc.

K number K252859

DQK 2026-04-20

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K number K260212

DQK 2026-04-13

ACORYS MAPPING SYSTEM

Applicant Corify Care S.L

K number K253861

DQK 2026-04-01

Synchrony

Applicant Stereotaxis, Inc.

K number K253473

DQK 2026-02-24

HemoSphere Nano Monitor (HSNANO1)

K number K253186

DQK 2026-02-20

CARTO™ 3 EP Navigation System V8.4

Applicant Biosense Webster, Inc.

K number K252972

DQK 2026-02-17

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

K number K254089

DQK 2026-02-09

Holter ECG and ABP system (HolterABP)

Applicant Edan Instruments, Inc.

K number K251591

DQK 2026-02-06

SafeBeat Rx App

Applicant SafeBeat Rx, Inc.

K number K251218

DQK 2026-01-28

NorthStar™ Mapping System

Applicant Imricor Medical Systems

K number K252164

DQK 2026-01-18

CARTO™ 3 EP Navigation System V9.0 with PIU Plus

Applicant Biosense Webster, Inc.

K number K254085

DQK 2025-12-19

STAR Apollo™ Mapping System

Applicant Rhythm AI, Ltd.

K number K253733

DQK 2025-12-18

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

Applicant Edwards Lifesciences

K number K252533

DQK 2025-12-11

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K number K253141

DQK 2025-12-04

Vektor Computational ECG Mapping System (vMap®)

Applicant Vektor Medical, Inc.

K number K252429

DQK 2025-10-24

LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K number K252645

DQK 2025-10-24

CoroFlow Cardiovascular System

Applicant Coroventis Research AB

K number K252238

DQK 2025-10-21

HemoSphere Stream Module

Applicant Edwards Lifesciences

K number K253034

DQK 2025-09-25

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K number K252013

DQK 2025-09-12

Volta AF-Xplorer II

Applicant Volta Medical

K number K251518

DQK 2025-09-04

EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite™ X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)

Applicant ABBOTT MEDICAL

K number K251463

DQK 2025-08-22

CARTO™ 3 EP Navigation System V8.1

Applicant Biosense Webster, Inc.

K number K252302

DQK 2025-07-30

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K number K251234

DQK 2025-07-23

HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

Applicant Edwards Lifesciences

K number K243781

DQK 2025-06-25

Globe® Pulsed Field System

Applicant Kardium, Inc.

K number K250747

DQK 2025-06-04

PhysCade System

Applicant Physcade, Inc.

K number K250749

DQK 2025-05-28

OptiMap™ System

Applicant Boston Scientific Corporation

K number K251344

DQK 2025-05-27

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K number K250932

DQK 2025-05-09

Volta AF-Xplorer

Applicant Volta Medical

K number K243812

DQK 2025-04-17

VitalRhythm

Applicant Vitalconnect, Inc.

K number K242129

DQK 2025-03-06

Intra-Operative Positioning System (IOPS®)

K number K243842

DQK 2025-02-20

CER-S

Applicant Cardiocalm Srl

K number K243312

DQK 2025-01-17

Affera Integrated Mapping System

Applicant Medtronic, Inc.

K number K243892

DQK 2024-12-12

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

Applicant Ge Medical Systems Information Technologies, Inc.

K number K243540

DQK 2024-12-05

Magnetic Localization Patch Kit (AFR-00021)

Applicant Medtronic, Inc.

K number K243435

DQK 2024-12-04

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K number K241197

DQK 2024-11-01

Affera Integrated Mapping System; Impedance Localization Patch Kit

Applicant Medtronic, Inc.

K number K241828

DQK 2024-10-11

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)

K number K242133

DQK 2024-08-29

RHYTHMIA HDx™ Mapping System

Applicant Boston Scientific Corporation

K number K241227

DQK 2024-08-16

HeartKey® Rhythm

Applicant B-Secur Limited

K number K233755

DQK 2024-08-09

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K number K242016

DQK 2024-07-26

STAR Apollo™ Mapping System

Applicant Rhythm AI, Ltd.

K number K240509

DQK 2024-07-24

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)

K number K241243

DQK 2024-06-21

Merge Hemo, Model RCSV2

Applicant Merge Healthcare Incorporated

K number K233326

DQK 2024-03-14

LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K number K233853

DQK 2024-03-08

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

Applicant Medtronic, Inc.

K number K233943

DQK 2023-12-13

CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

Applicant Ge Medical Systems Information Technologies, Inc.

K number K231870

DQK 2023-11-25

NeuTrace EP Mapping System v.2.1

Applicant Anumana, Inc.

K number K233160

DQK 2023-10-31

HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advanced Monitor (Cardiac); HemoSphere Alta™ Advanced Monitor (All-on-One)

K number K232294

DQK 2023-09-27

Volta AF-Xplorer

Applicant Volta Medical

K number K232616

DQK 2023-09-26

AVVIGO'+ Multi-Modality Guidance System

Applicant Boston Scientific Corporation

K number K230884

DQK 2023-09-15

Sensis Vibe (VD15)

Applicant Siemens Medical Solutions USA, Inc.

K number K223812

DQK 2023-09-07

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

Applicant Biosense Webster, Inc.

K number K231207

DQK 2023-08-18

Smart Wedge algorithm

K number K230579

DQK 2023-08-10

EnSite™ X EP System

Applicant ABBOTT MEDICAL

K number K231415

DQK 2023-08-04

ECGenius System

Applicant Cath Vision Aps

K number K223787

DQK 2023-08-01

Nuubo Smart

Applicant Smart Solutions Technologies SL

K number K231620

DQK 2023-07-12

FusedCO Algorithm

K number K231035

DQK 2023-07-10

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K231091

DQK 2023-06-21

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)

K number K230309

DQK 2023-06-09

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

K number K223865

DQK 2023-06-08

Ablamap® System

Applicant Ablacon, Inc.

K number K230008

DQK 2023-06-08

AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub

Applicant Philips Medical Systems Nederland B.V.

K number K223918

DQK 2023-05-02

AcQMap® High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K230606

DQK 2023-02-16

CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4

Applicant Biosense Webster, Inc.

K number K223733

DQK 2023-02-15

ZEUS System

Applicant iRhythm Technologies, Inc.

K number K222389

DQK 2023-01-21

VX1+

Applicant Volta Medical

K number K223516

DQK 2022-12-29

EndoPATx

Applicant Itamar Medical , Ltd.

K number K211557

DQK 2022-12-27

EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software License

Applicant ABBOTT MEDICAL

K number K223094

DQK 2022-12-01

STAR Apollo Mapping System

Applicant Rhythm Al, Ltd.

K number K220786

DQK 2022-11-22

HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

K number K221704

DQK 2022-11-07

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

Applicant Edwards Lifeciences, LLC

K number K223127

DQK 2022-10-24

KODEX – EPD™ System 1.5.0

Applicant Philips Medical Systems Nederland, B.V. (Pmsn)

K number K212493

DQK 2022-10-17

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K222209

DQK 2022-08-18

EnSite X EP System

Applicant Abbott

K number K221213

DQK 2022-08-17

CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)

Applicant Biosense Webster, Inc.

K number K221112

DQK 2022-07-27

DeepRhythmAI

Applicant Medicalgorithmics S.A.

K number K210822

DQK 2022-07-19

ZEUS System (Zio Watch)

Applicant iRhythm Technologies, Inc.

K number K213409

DQK 2022-07-01

AcQMap High Resolution Imaging and Mapping System

Applicant Acutus Medical, Inc.

K number K220784

DQK 2022-06-22

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, Acumen Assisted Fluid Management Feature, Viewfinder Remote

K number K213682

DQK 2022-05-03

ECGenius System

Applicant Cath Vision Aps

K number K220306

DQK 2022-04-30

Ultiri Measurement System

Applicant ABBOTT MEDICAL

K number K220243

DQK 2022-04-26

AliveCor QT Service

Applicant AliveCor, Inc.

K number K212662

DQK 2022-04-25

CER-S

Applicant Cardiocalm Srl

K number K213861

DQK 2022-02-17

Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX

Applicant Ge Healthcare Information Technologies, Inc.

K number K213972

DQK 2022-01-11

Cardiovascular Suite 4.2.1

Applicant Quipu S.R.L

K number K202094

DQK 2021-11-11

EnSite X EP System

Applicant ABBOTT MEDICAL

K number K213364

DQK 2021-11-09

Vektor Computational ECG Mapping System (vMap)

Applicant Vektor Medical, Inc.

K number K211546

DQK 2021-11-03

IM007

Applicant Implicity, Inc.

K number K210543

DQK 2021-10-29

CARTO 3 EP Navigation System Version 7.2

Applicant Biosense Webster, Inc.

K number K213264