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

DateFirm and productCodeLinked 510(k)
Sep 11, 2026GE Medical Systems Information Technologies Inc
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Open, Classified
DQKK162012
Jun 1, 2026GE Medical Systems Information Technologies Inc
CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3
Open, Classified
DQKK231870
Oct 31, 2025Spacelabs Healthcare, Ltd.
Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software Version: 11.6.0 Product Description: Cardiology Information Management System Component: No The Sentinel Cardi
Open, Classified
DQKK152881
Sep 4, 2025Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that mo
Open, Classified
DQKK233326
May 19, 2025Centerline Biomedical Inc
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Open, Classified
DQKK190106
K230309 +3
Oct 17, 2024CHANGE HEALTHCARE CANADA COMPANY
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Open, Classified
DQKK131497
Oct 17, 2024CHANGE HEALTHCARE CANADA COMPANY
Horizon Cardiology Hemo. Version 12.2.
Open, Classified
DQKK050561
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracard
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or int
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or
Open, Classified
DQKK230884
Oct 16, 2024Boston Scientific Corporation
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intr
Open, Classified
DQKK230884
Jul 25, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as wel
Open, Classified
DQKK223812
Jul 25, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic cathete
Open, Classified
DQKNone listed
Jul 25, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizatio
Open, Classified
DQKNone listed
Jul 25, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or e
Open, Classified
DQKK223812
Jul 3, 2024GE Medical Systems Information Technologies Inc
Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording system and ComboLab AltiX hemodynamic and electrophysiology recording system; and Field Replacement Units spare
Open, Classified
DQKK050093
Jan 9, 2024Siemens Medical Solutions USA, Inc
Sensis Vibe Hemo
Open, Classified
DQKK223812
Dec 14, 2023APN Health LLC
Navik 3D v2, REF NAVIK3D, 3D Mapping System
Open, Classified
DQKK152160
Sep 28, 2023Baxter Healthcare Corporation
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Open, Classified
DQKK052883
Sep 19, 2023GE Medical Systems Information Technologies Inc
Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
Open, Classified
DQKK213972
Jan 1, 2023Siemens Medical Solutions USA, Inc
Programmable Diagnostic Computer
Open, Classified
DQKK150493
Jul 12, 2022Siemens Medical Solutions USA, Inc
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AX
Terminated
DQKK150493
Jun 15, 2022Siemens Medical Solutions USA, Inc
Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Rad
Open, Classified
DQKK150493
Jun 15, 2022Siemens Medical Solutions USA, Inc
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Mo
Open, Classified
DQKK150493
Jun 6, 2022Siemens Medical Solutions USA, Inc
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 1076550
Open, Classified
DQKK150493
Apr 25, 2022CardioTek BV
CardioTek EP-TRACER Software V2.x.
Completed
DQKK183266
Mar 16, 2022GE Healthcare, LLC
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Terminated
DQKK152993
Jan 14, 2022Siemens Medical Solutions USA, Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis reco
Open, Classified
DQKK150493
Jul 23, 2021Merge Healthcare, Inc.
Merge Hemo, Software packages 10.2, 10.3, and 10.4
Terminated
DQKK152864
May 5, 2021Abbott Laboratories Inc. (St Jude Medical)
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Terminated
DQKK210392
May 5, 2021Abbott Laboratories Inc. (St Jude Medical)
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system d
Terminated
DQKK210392
May 5, 2021Abbott Laboratories Inc. (St Jude Medical)
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed fo
Terminated
DQKK210392

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