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
Dec 4, 2013K132437MARS HOLTER ANALYSIS WORKSTATION
Ge Medical Systems Information Technologies, Inc.
DQK
Sep 9, 2013K132073EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
St Jude Medical
DQK
Aug 29, 2013K130727ENSITE VELOCITY SYSTEM
St Jude Medical
DQK
Aug 23, 2013K130516CARDIODAY
Getemed Medizin- Und Informationstechnik AG, DE
DQK
Jul 25, 2013K131812SENSIS, SENSIS LITE
Siemens Medi Cal Solutions, Inc.
DQK
Jul 22, 2013K130750RHYTHMIA MAPPING SYSTEM
Rhythmia Medical, Inc.
DQK
May 29, 2013K131045ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
Cardiac Designs, LLC
DQK
May 3, 2013K130594ENSITE VELOCITY SYSTEM
St Jude Medical
DQK
May 1, 2013K130626MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
Ge Medical Systems Information Technologies, Inc.
DQK
Apr 24, 2013K123295RHYTHM VIEW
Topera, Inc.
DQK
Mar 28, 2013K123984QUANTIEN MEASUREMENT SYSTEM
Radi Medical Systems AB, SE
DQK
Mar 1, 2013K130155MUSE CARDIOLOGY INFORMATION SYSTEM
Ge Medical Systems Information Technologies, Inc.
DQK
Dec 20, 2012K123466HEALTHVIEW ECG MANAGER
Lumedx
DQK
Jul 18, 2012K121638ST80I STRESS TEST SYSTEM
Philips Health Care
DQK
Jun 29, 2012K120855INTELLISPACE ECG
Philips Health Care
DQK
May 7, 2012K120550CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)
Biosense Webster, Inc.
DQK
Mar 16, 2012K113811V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM
C.R. Bard Inc., Bard Electrophysiology Division
DQK
Mar 16, 2012K113515HORIZON CARDIOLOGY ECG MANAGEMENT
Mckesson Israel , Ltd., IL
DQK
Feb 24, 2012K120301MEDIGUIDE TECHNOLOGY
St. Jude Medical, Mediguide Navigation Systems
DQK
Nov 9, 2011K112688ENSITE VELOCITY SYSTEM V.3.0
St Jude Medical
DQK
Oct 12, 2011K111200MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM
GE Healthcare
DQK
Oct 5, 2011K112007CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
Biosense Webster, Inc.
DQK
Sep 23, 2011K110878RHYTHMVIEW (TM)
Topera, Inc.
DQK
Jun 14, 2011K110001SPACELABS PATHFINDER SL HOLTER ANALYZER
Spacelabs Healthcare, Ltd.
DQK
May 25, 2011K110132MUSE CARDIOLOGY INFORMATION SYSTEM
Ge Medical Systems Information Technologies, Inc.
DQK
May 24, 2011K1107464D LV-ANALYSIS 3.0
Tomtec Imaging Systems GmbH, DE
DQK
May 5, 2011K110549ENSITE VELOCITY SYSTEM
St Jude Medical
DQK
Apr 19, 2011K110779SPACELABS SMART DISCLOSURE SYSTEM
Spacelabs Healthcare
DQK
Feb 16, 2011K103678CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM
Ge Medical Systems Information Technologies GmbH, DE
DQK
Jan 27, 2011K1037824D MV-ASSESSMENT 2.0
Tomtec Imaging Systems GmbH, DE
DQK
Jan 21, 2011K103746CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
Biosense Webster, Inc.
DQK
Oct 29, 2010K102905GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II)
Mediguide, Ltd.
DQK
Oct 8, 2010K101331LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
C.R. Bard Inc., Bard Electrophysiology Division
DQK
Jul 14, 2010K101328ENSITE VELOCITY SYSTEM
St Jude Medical
DQK
Jul 2, 2010K101667ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
St Jude Medical
DQK
Jun 18, 2010K093566CARTO XP EP NAVIGATION SYSTEM, VERSION 10
Biosense Webster, Inc.
DQK
Jun 11, 2010K101419ENSITE VELOCITY SYSTEM, MODEL EE3000
St Jude Medical
DQK
Apr 14, 2010K100362CAMBRIDGE HEART OEM
Cambridge Heart, Inc.
DQK
Feb 25, 2010K093942ENSITE VELOCITY SYSTEM V1.3
St Jude Medical
DQK
Jan 21, 2010K093092ODYSSEY WORKSTATION
Stereotaxis, Inc.
DQK
Dec 29, 2009K093141MARS HOLTER ANALYSIS WORKSTATION
Ge Medical Systems Information Technologies
DQK
Dec 15, 2009K093583EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
St Jude Medical
DQK
Dec 4, 2009K093455CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES
Biosense Webster, Inc.
DQK
Oct 16, 2009K091781GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
Mediguide, Ltd.
DQK
Oct 13, 2009K090017CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES
Biosense Webster, Inc.
DQK
Oct 9, 2009K092810EP-WORKMATE SYSTEM, VERSION 4.2
St Jude Medical
DQK
Oct 9, 2009K092105RADIANALYZER XPRESS
Radi Medical Systems AB, SE
DQK
Oct 1, 2009K091789CARTO RMT EP NAVIGATION SYSTEM V8
Biosense Webster, Inc.
DQK
Aug 7, 2009K091165HORIZON XVU
Mennen Medical , Ltd., IL
DQK
Jul 21, 2009K091075ZEUS (ZIO ECG UTILIZATION SERVICE) SYSTEM
iRhythm Technologies, Inc.
DQK

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