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FDA 510(k)

iMap 3D Mapping & Navigation System (iMap System)

K-Number: K201094 · 2021-08-16

ApplicantCardionxt, Inc.
Decision Date2021-08-16
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

iMap 3D Mapping & Navigation System (iMap System) is a medical device manufactured by Cardionxt, Inc.. It received FDA 510(k) clearance on 2021-08-16 under approval number K201094. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iMap 3D Mapping & Navigation System (iMap System)?

iMap 3D Mapping & Navigation System (iMap System) is a medical device that received FDA 510(k) clearance on 2021-08-16. It is manufactured by Cardionxt, Inc.. The 510(k) number is K201094.

When was iMap 3D Mapping & Navigation System (iMap System) approved by the FDA?

iMap 3D Mapping & Navigation System (iMap System) received FDA 510(k) clearance on 2021-08-16, under approval number K201094.

What company makes iMap 3D Mapping & Navigation System (iMap System)?

iMap 3D Mapping & Navigation System (iMap System) is manufactured by Cardionxt, Inc..

What is the FDA product code for iMap 3D Mapping & Navigation System (iMap System)?

The FDA product code for iMap 3D Mapping & Navigation System (iMap System) is DQK.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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