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FDA 510(k)

AcQMap High Resolution Imaging and Mapping System

K-Number: K201015 · 2020-12-01

ApplicantAcutus Medical, Inc.
Decision Date2020-12-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQMap High Resolution Imaging and Mapping System is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-12-01 under approval number K201015. 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 AcQMap High Resolution Imaging and Mapping System?

AcQMap High Resolution Imaging and Mapping System is a medical device that received FDA 510(k) clearance on 2020-12-01. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K201015.

When was AcQMap High Resolution Imaging and Mapping System approved by the FDA?

AcQMap High Resolution Imaging and Mapping System received FDA 510(k) clearance on 2020-12-01, under approval number K201015.

What company makes AcQMap High Resolution Imaging and Mapping System?

AcQMap High Resolution Imaging and Mapping System is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQMap High Resolution Imaging and Mapping System?

The FDA product code for AcQMap High Resolution Imaging and Mapping System is DQK.

Related Clinical Trials

NCT07475091 Standardizing Swallow Pressure Measurements NOT_YET_RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING 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 NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41293705 Clinical translation of photoacoustic imaging using exogenous molecular contrast agents [Invited]. Biomedical optics express (2025) 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)

Other Devices by Acutus Medical, Inc.

K170948AcQMap High Resolution Imaging and Mapping System K170819AcQMap 3D Imaging and Mapping Catheter K162925AcQGuide Steerable Sheath K171557AcQRef Introducer Sheath K191392AcQMap High Resolution Imaging and Mapping System K192106AcQRef Introducer Sheath

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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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