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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 the device name listed in this FDA 510(k) record. The listed applicant is Cardionxt, Inc.. It received FDA 510(k) clearance on 2021-08-16 under 510(k) 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. The listed applicant is Cardionxt, Inc.. The 510(k) number is K201094.

When did iMap 3D Mapping & Navigation System (iMap System) receive FDA 510(k) clearance?

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

Who is the listed applicant for iMap 3D Mapping & Navigation System (iMap System)?

The FDA 510(k) record lists Cardionxt, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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