Cleared Traditional

AcQMap? High Resolution Imaging and Mapping System

K230606 · Acutus Medical, Inc. · Cardiovascular
May 2023
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K230606 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 May 2, 2023, 60 days after receiving the submission on March 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K230606 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2023
Decision Date May 02, 2023
Days to Decision 60 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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