Computer, Diagnostic, Programmable

FDA product code DQK · 422 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1425
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-10-13 – 2026-09-17

DQK 2011-10-12

MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM

Applicant GE Healthcare

K number K111200

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DQK 2011-10-05

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

Applicant Biosense Webster, Inc.

K number K112007

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DQK 2011-09-23

RHYTHMVIEW (TM)

Applicant Topera, Inc.

K number K110878

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DQK 2011-06-14

SPACELABS PATHFINDER SL HOLTER ANALYZER

Applicant Spacelabs Healthcare, Ltd.

K number K110001

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DQK 2011-05-25

MUSE CARDIOLOGY INFORMATION SYSTEM

Applicant Ge Medical Systems Information Technologies, Inc.

K number K110132

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DQK 2011-05-24

4D LV-ANALYSIS 3.0

Applicant Tomtec Imaging Systems GmbH

K number K110746

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DQK 2011-05-05

ENSITE VELOCITY SYSTEM

Applicant St Jude Medical

K number K110549

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DQK 2011-04-19

SPACELABS SMART DISCLOSURE SYSTEM

Applicant Spacelabs Healthcare

K number K110779

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DQK 2011-02-16

CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM

Applicant Ge Medical Systems Information Technologies GmbH

K number K103678

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DQK 2011-01-27

4D MV-ASSESSMENT 2.0

Applicant Tomtec Imaging Systems GmbH

K number K103782

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DQK 2011-01-21

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)

Applicant Biosense Webster, Inc.

K number K103746

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DQK 2010-10-29

GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)

Applicant Mediguide, Ltd.

K number K102905

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DQK 2010-10-08

LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE

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

K number K101331

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DQK 2010-07-14

ENSITE VELOCITY SYSTEM

Applicant St Jude Medical

K number K101328

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DQK 2010-07-02

ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)

Applicant St Jude Medical

K number K101667

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DQK 2010-06-18

CARTO XP EP NAVIGATION SYSTEM, VERSION 10

Applicant Biosense Webster, Inc.

K number K093566

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DQK 2010-06-11

ENSITE VELOCITY SYSTEM, MODEL EE3000

Applicant St Jude Medical

K number K101419

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DQK 2010-04-14

CAMBRIDGE HEART OEM

Applicant Cambridge Heart, Inc.

K number K100362

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DQK 2010-02-25

ENSITE VELOCITY SYSTEM V1.3

Applicant St Jude Medical

K number K093942

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DQK 2010-01-21

ODYSSEY WORKSTATION

Applicant Stereotaxis, Inc.

K number K093092

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DQK 2009-12-29

MARS HOLTER ANALYSIS WORKSTATION

Applicant Ge Medical Systems Information Technologies

K number K093141

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DQK 2009-12-15

EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE

Applicant St Jude Medical

K number K093583

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DQK 2009-12-04

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

Applicant Biosense Webster, Inc.

K number K093455

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DQK 2009-10-16

GUIDED MEDICAL POSITIONING SYSTEM (GMPS)

Applicant Mediguide, Ltd.

K number K091781

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DQK 2009-10-13

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

Applicant Biosense Webster, Inc.

K number K090017

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DQK 2009-10-09

EP-WORKMATE SYSTEM, VERSION 4.2

Applicant St Jude Medical

K number K092810

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DQK 2009-10-09

RADIANALYZER XPRESS

Applicant Radi Medical Systems AB

K number K092105

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DQK 2009-10-01

CARTO RMT EP NAVIGATION SYSTEM V8

Applicant Biosense Webster, Inc.

K number K091789

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DQK 2009-08-07

HORIZON XVU

Applicant Mennen Medical , Ltd.

K number K091165

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DQK 2009-07-21

ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM

Applicant iRhythm Technologies, Inc.

K number K091075

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DQK 2009-05-22

ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010

Applicant St Jude Medical

K number K083328

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DQK 2009-02-17

MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE

Applicant Ge Medical Systems Information Technologies

K number K083639

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DQK 2008-12-17

HEARTSUITE HEMODYNAMICS 7.10

Applicant Emageon, Inc.

K number K082421

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DQK 2008-10-31

BP LIMBO XL, BPTANGO XL, BP SALSA XL

Applicant Datadancer Medical Systems

K number K072752

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DQK 2008-09-11

ENSITE FUSION DYNAMIC REGISTRATION TOOL

Applicant St Jude Medical

K number K082467

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DQK 2008-06-20

HORIZON XVU

Applicant Mennen Medical , Ltd.

K number K081484

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DQK 2007-12-20

ENSITE FUSION DYNAMIC REGISTRATION TOOL

Applicant St Jude Medical

K number K071818

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DQK 2007-11-19

MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K072502

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DQK 2007-11-19

CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)

Applicant Biosense Webster, Inc.

K number K072202

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DQK 2007-11-02

VENDYS, MODEL 6000 B B/C

Applicant Endothelix, Inc.

K number K072919

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DQK 2007-09-07

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR

Applicant Innovision A/S

K number K071911

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DQK 2007-09-07

EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM

Applicant Mennen Medical , Ltd.

K number K071348

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DQK 2007-08-16

VENDYS MODEL 5000 B/BC

Applicant Endothelix, Inc.

K number K060980

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DQK 2007-05-04

CARTO XP EP NAVIGATION SYSTEM, VERSION 9

Applicant Biosense Webster, Inc.

K number K070240

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DQK 2007-05-01

MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

Applicant St Jude Medical

K number K070902

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DQK 2007-04-19

HORIZON SE

Applicant Mennen Medical , Ltd.

K number K070254

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DQK 2007-04-11

EP-WORKMATE

Applicant Ep Medsystems

K number K070706

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DQK 2007-03-15

SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

Applicant Spacelabs Medical, Inc.

K number K063490

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DQK 2007-02-23

CARDIODAY, VERSION 2.0

Applicant Getemed Medizin- Und Informationstechnik AG

K number K070280

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DQK 2006-11-30

MAPMATE

Applicant Ep Medsystems, Inc.

K number K063277

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DQK 2006-11-08

HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0

Applicant Medcon , Ltd.

K number K061905

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DQK 2006-10-27

EP-WORKMATE

Applicant Ep Medsystems

K number K063113

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DQK 2006-09-15

MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM

Applicant GE Healthcare

K number K061741

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DQK 2006-04-21

MODIFICATION TO ENSITE SYSTEM, MODEL EE3000

Applicant St. Jude Medical, Inc.-Endocardial Solutions

K number K060954

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DQK 2006-03-09

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

Applicant Biosense Webster, Inc.

K number K053194

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DQK 2006-03-02

INNOCOR

Applicant Innovision A/S

K number K051907

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DQK 2006-01-13

DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES

Applicant GE Healthcare

K number K052976

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DQK 2005-12-22

MEDILOG DARWIN HOLTER ANALYSIS

Applicant Huntleigh Healthcare

K number K053369

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DQK 2005-11-22

DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES

Applicant GE Healthcare

K number K052977

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DQK 2005-11-01

CARDIOSERVER

Applicant Datrix

K number K052883

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DQK 2005-09-29

CARTO RMT EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K042681

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DQK 2005-07-19

MARS HOLTER ANALYSIS WORKSTATION

Applicant Ge Medical Systems Information Technologies

K number K051026

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DQK 2005-06-29

CARDIODAY

Applicant Getemed Medizin- Und Informationstechnik AG

K number K051471

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DQK 2005-05-13

MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K050093

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DQK 2005-05-04

WINDSURFER

Applicant Medcon , Ltd.

K number K050561

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DQK 2005-04-29

LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE

Applicant Vivometrics, Inc.

K number K043604

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DQK 2005-04-07

HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM

Applicant Cambridge Heart, Inc.

K number K050225

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DQK 2005-04-05

MUSE CARDIOLOGY INFORMATION SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K050614

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DQK 2005-03-21

CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8

Applicant Biosense Webster, Inc.

K number K042999

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DQK 2005-01-27

HORIZON ANGIO CATHLAB

Applicant Mennen Medical , Ltd.

K number K043564

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DQK 2005-01-26

CARDIOSTATION-100 (CS-100)

Applicant Us Clover Co.

K number K041031

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DQK 2005-01-19

MODIFICATION TO: RADIANALYZER, MODEL 12711

Applicant Radi Medical Systems AB

K number K042628

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DQK 2005-01-13

CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD)

Applicant Cardiobiomedical Corporation

K number K042849

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DQK 2004-12-16

VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS

Applicant Medical Imaging Applications, LLC

K number K033266

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DQK 2004-12-03

HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES

Applicant Ge Medical Syst. Information Technologies

K number K042148

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DQK 2004-10-22

QRS-CARD CARDIOLOGY SUITE

Applicant Pulse Biomedical, Inc.

K number K042799

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DQK 2004-10-20

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER

Applicant Ela Medical, Inc.

K number K042002

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DQK 2004-10-15

ENSITE SYSTEM, MODEL EE3000

Applicant Endocardial Solutions, Inc.

K number K042493

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DQK 2004-09-22

HOLTER PLUS

Applicant Rozinn Electronics, Inc.

K number K042463

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DQK 2003-11-12

ENDO PAT 2000

Applicant Itamar Medical

K number K032519

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DQK 2003-10-30

ENSITE SYSTEM

Applicant Endocardial Solutions, Inc.

K number K033211

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DQK 2003-10-30

T-WAVE ALTERNANS (TWA) ALGORITHM OPTION

Applicant Ge Medical Systems Information Technologies

K number K032513

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DQK 2003-10-10

MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K032577

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DQK 2003-09-17

GALIX WINTER

Applicant Galix Biomedical Instrumentation, Inc.

K number K030145

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DQK 2003-09-09

INFINITY MEGACARE

Applicant Siemens Medical Solutions USA, Inc.

K number K031970

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DQK 2003-09-05

PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601

Applicant Quinton, Inc.

K number K032038

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DQK 2003-08-20

EP-WORKMATE WITH RPM SYSTEM

Applicant Ep Medsystems

K number K032225

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DQK 2003-08-01

CARDIOSOFT/CASE CARDIAC TESTING SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K031561

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DQK 2003-07-29

REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE

Applicant Vivometrics, Inc.

K number K031550

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DQK 2003-06-03

LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0

Applicant C.R. Bard, Inc.

K number K031000

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DQK 2003-04-22

MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000

Applicant Endocardial Solutions, Inc.

K number K030129

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DQK 2003-01-31

BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD)

Applicant Clover Hi-Tech, Inc.

K number K022596

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DQK 2003-01-09

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

Applicant Biosense Webster, Inc.

K number K020863

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DQK 2002-12-24

CHEETAH I.V.D.S., MODEL 2002P

Applicant Cheetah Medical, Inc.

K number K023370

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DQK 2002-12-17

PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9

Applicant Problem Solving Concepts, Inc.

K number K023112

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DQK 2002-12-03

T-WAVE ALTERMANS (TWA) ALGORITHM OPTION

Applicant General Electric Medical Systems Information Techn

K number K023380

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DQK 2002-12-03

NEWCOR

Applicant Siemens Medical Systems, Inc.

K number K020440

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DQK 2002-10-03

RADIANALYZER, MODEL 12710

Applicant Radi Medical Systems AB

K number K022188

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DQK 2002-10-01

QIVA

Applicant Pie Medical Imaging BV

K number K021495

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DQK 2002-09-25

CARDIS

Applicant Schwarzer GmbH

K number K023015

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