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)
Top companies in DQK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | GE 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 |
DQK | K162012 |
| Jun 1, 2026 | GE Medical Systems Information Technologies Inc CASE v7.0 Cardiac Testing System
Model no. 3031234-001
Product Code SU3 Open, Classified |
DQK | K231870 |
| Oct 31, 2025 | Spacelabs 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 |
DQK | K152881 |
| Sep 4, 2025 | Merge 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 |
DQK | K233326 |
| May 19, 2025 | Centerline 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 |
DQK | K190106 K230309 +3 |
| Oct 17, 2024 | CHANGE HEALTHCARE CANADA COMPANY McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0. Open, Classified |
DQK | K131497 |
| Oct 17, 2024 | CHANGE HEALTHCARE CANADA COMPANY Horizon Cardiology Hemo. Version 12.2. Open, Classified |
DQK | K050561 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Oct 16, 2024 | Boston 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 |
DQK | K230884 |
| Jul 25, 2024 | Siemens 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 |
DQK | K223812 |
| Jul 25, 2024 | Siemens 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 |
DQK | None listed |
| Jul 25, 2024 | Siemens 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 |
DQK | None listed |
| Jul 25, 2024 | Siemens 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 |
DQK | K223812 |
| Jul 3, 2024 | GE 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 |
DQK | K050093 |
| Jan 9, 2024 | Siemens Medical Solutions USA, Inc Sensis Vibe Hemo Open, Classified |
DQK | K223812 |
| Dec 14, 2023 | APN Health LLC Navik 3D v2, REF NAVIK3D, 3D Mapping System Open, Classified |
DQK | K152160 |
| Sep 28, 2023 | Baxter 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 |
DQK | K052883 |
| Sep 19, 2023 | GE 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 |
DQK | K213972 |
| Jan 1, 2023 | Siemens Medical Solutions USA, Inc Programmable Diagnostic Computer Open, Classified |
DQK | K150493 |
| Jul 12, 2022 | Siemens 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 |
DQK | K150493 |
| Jun 15, 2022 | Siemens 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 |
DQK | K150493 |
| Jun 15, 2022 | Siemens 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 |
DQK | K150493 |
| Jun 6, 2022 | Siemens Medical Solutions USA, Inc Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633
6634658 6648153
6648161 10140973
10764561 1076550 Open, Classified |
DQK | K150493 |
| Apr 25, 2022 | CardioTek BV CardioTek EP-TRACER Software V2.x. Completed |
DQK | K183266 |
| Mar 16, 2022 | GE Healthcare, LLC MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008 Terminated |
DQK | K152993 |
| Jan 14, 2022 | Siemens 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 |
DQK | K150493 |
| Jul 23, 2021 | Merge Healthcare, Inc. Merge Hemo, Software packages 10.2, 10.3, and 10.4 Terminated |
DQK | K152864 |
| May 5, 2021 | Abbott Laboratories Inc. (St Jude Medical) WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012 Terminated |
DQK | K210392 |
| May 5, 2021 | Abbott 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 |
DQK | K210392 |
| May 5, 2021 | Abbott 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 |
DQK | K210392 |
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