Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AcQMap High Resolution Imaging and Mapping System

K-Number: K231091 · 2023-07-10

ApplicantAcutus Medical, Inc.
Decision Date2023-07-10
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQMap High Resolution Imaging and Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K231091. 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 2023-07-10. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K231091.

When did AcQMap High Resolution Imaging and Mapping System receive FDA 510(k) clearance?

AcQMap High Resolution Imaging and Mapping System received FDA 510(k) clearance on 2023-07-10, under 510(k) number K231091.

Who is the listed applicant for AcQMap High Resolution Imaging and Mapping System?

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

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

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.

NCT07699783Transcranial Ultrasound Stimulation for Tourette SyndromeNOT_YET_RECRUITING

Other records listing Acutus Medical, Inc. as applicant

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.

K233691FlexCath Cross Transseptal SolutionK230606AcQMap® High Resolution Imaging and Mapping SystemK222209AcQMap High Resolution Imaging and Mapping SystemK220784AcQMap High Resolution Imaging and Mapping SystemK210766AcQMap 3D Imaging and Mapping Catheter, Model 900009K221044AcQGuide® VUE Steerable Sheath

View all 24 devices →

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.

↑