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

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
Aug 29, 2024K241227RHYTHMIA HDx™ Mapping System
Boston Scientific Corporation
DQK
Aug 16, 2024K233755HeartKey® Rhythm
B-Secur Limited, GB
DQK
Aug 9, 2024K242016EnSite™ X EP System
ABBOTT MEDICAL
DQK
Jul 26, 2024K240509STAR Apollo™ Mapping System
Rhythm AI, Ltd., GB
DQK
Jul 24, 2024K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®
Centerline Biomedical, Inc.
DQK
Jun 21, 2024K233326Merge Hemo, Model RCSV2
Merge Healthcare Incorporated
DQK
Mar 14, 2024K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
Philips Medical Systems Nederland B.V., NL
DQK
Mar 8, 2024K233943Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
Medtronic, Inc.
DQK
Dec 13, 2023K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Ge Medical Systems Information Technologies, Inc.
DQK
Nov 25, 2023K233160NeuTrace EP Mapping System v.2.1
Anumana, Inc.
DQK
Oct 31, 2023K232294HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta™ Advanced Monitor (Smart Recovery); HemoSphere Alta™ Advan
Edwards Lifesciences, LLC
DQK
Sep 27, 2023K232616Volta AF-Xplorer
Volta Medical, FR
DQK
Sep 26, 2023K230884AVVIGO'+ Multi-Modality Guidance System
Boston Scientific Corporation
DQK
Sep 15, 2023K223812Sensis Vibe (VD15)
Siemens Medical Solutions USA, Inc.
DQK
Sep 7, 2023K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
Biosense Webster, Inc.
DQK
Aug 18, 2023K230579Smart Wedge algorithm
Edwards Lifesciences, LLC
DQK
Aug 10, 2023K231415EnSite™ X EP System
ABBOTT MEDICAL
DQK
Aug 4, 2023K223787ECGenius System
Cath Vision Aps, DK
DQK
Aug 1, 2023K231620Nuubo Smart
Smart Solutions Technologies SL, ES
DQK
Jul 12, 2023K231035FusedCO Algorithm
Edwards Lifesciences, LLC
DQK
Jul 10, 2023K231091AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Jun 21, 2023K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (R
Centerline Biomedical, Inc.
DQK
Jun 9, 2023K223865HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen
Edwards Lifesciences, LLC
DQK
Jun 8, 2023K230008Ablamap® System
Ablacon, Inc.
DQK
Jun 8, 2023K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
Philips Medical Systems Nederland B.V., NL
DQK
May 2, 2023K230606AcQMap® High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Feb 16, 2023K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4
Biosense Webster, Inc.
DQK
Feb 15, 2023K222389ZEUS System
iRhythm Technologies, Inc.
DQK
Jan 21, 2023K223516VX1+
Volta Medical, FR
DQK
Dec 29, 2022K211557EndoPATx
Itamar Medical , Ltd., IL
DQK
Dec 27, 2022K223094EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; EnSite™ X EP System TactiFlex™ Abla
ABBOTT MEDICAL
DQK
Dec 1, 2022K220786STAR Apollo Mapping System
Rhythm Al, Ltd., GB
DQK
Nov 22, 2022K221704HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
Edwards Lifesciences, LLC
DQK
Nov 7, 2022K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Edwards Lifeciences, LLC
DQK
Oct 24, 2022K212493KODEX – EPD™ System 1.5.0
Philips Medical Systems Nederland, B.V. (Pmsn), NL
DQK
Oct 17, 2022K222209AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Aug 18, 2022K221213EnSite X EP System
Abbott
DQK
Aug 17, 2022K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
Biosense Webster, Inc.
DQK
Jul 27, 2022K210822DeepRhythmAI
Medicalgorithmics S.A., PL
DQK
Jul 19, 2022K213409ZEUS System (Zio Watch)
iRhythm Technologies, Inc.
DQK
Jul 1, 2022K220784AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
DQK
Jun 22, 2022K213682HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphe
Edwards Lifesciences, LLC
DQK
May 3, 2022K220306ECGenius System
Cath Vision Aps, DK
DQK
Apr 30, 2022K220243Ultiri Measurement System
ABBOTT MEDICAL
DQK
Apr 26, 2022K212662AliveCor QT Service
AliveCor, Inc.
DQK
Apr 25, 2022K213861CER-S
Cardiocalm Srl, IT
DQK
Feb 17, 2022K213972Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Softwa
Ge Healthcare Information Technologies, Inc.
DQK
Jan 11, 2022K202094Cardiovascular Suite 4.2.1
Quipu S.R.L, IT
DQK
Nov 11, 2021K213364EnSite X EP System
ABBOTT MEDICAL
DQK
Nov 9, 2021K211546Vektor Computational ECG Mapping System (vMap)
Vektor Medical, Inc.
DQK

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