Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K170948 · Acutus Medical, Inc. · Cardiovascular
Oct 2017
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K170948 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 October 16, 2017, 200 days after receiving the submission on March 30, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K170948 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2017
Decision Date October 16, 2017
Days to Decision 200 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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