Cleared Traditional

AcQMap High Resolution Imaging and Mapping System

K222209 · Acutus Medical, Inc. · Cardiovascular
Oct 2022
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K222209 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 17, 2022, 84 days after receiving the submission on July 25, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K222209 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date October 17, 2022
Days to Decision 84 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

Similar Devices — DQK Computer, Diagnostic, Programmable

All 423
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO? 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar? Mapping System
K252164 · Imricor Medical Systems · Jan 2026