Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K220784 · Acutus Medical, Inc. · Cardiovascular
Jul 2022
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K220784 is an FDA 510(k) clearance for the AcQMap High Resolution Imaging and Mapping System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 1, 2022, 106 days after receiving the submission on March 17, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K220784 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2022
Decision Date July 01, 2022
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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