AcQMap High Resolution Imaging and Mapping System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212345 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AcQMap High Resolution Imaging and Mapping System is a cardiac mapping system designed for use in electrophysiology procedures to map and visualize cardiac anatomy and electrical activity. It delivers ultra high resolution imaging and mapping to support individualized ablation strategies through real-time arrhythmia visualization.
The system is supplied as a non-sterile, reusable medical device intended for use in clinical electrophysiology settings. It is authorized under FDA 510(k) clearance (K212345) with product code DQK and was determined to be substantially equivalent to a predicate device. The system supports multiple mapping modes and is used to guide treatment decisions in cardiac care.
Frequently asked questions
What is the AcQMap High Resolution Imaging and Mapping System used for?
The AcQMap High Resolution Imaging and Mapping System is designed for use in electrophysiology procedures to map and visualize cardiac anatomy and electrical activity, delivering ultra high resolution imaging and mapping to support individualized ablation strategies through real-time arrhythmia visualization.
How is the AcQMap system supplied and is it reusable?
The system is supplied as a non-sterile, reusable medical device intended for use in clinical electrophysiology settings, meaning it can be cleaned and reused according to manufacturer instructions after each procedure.
What regulatory pathway was used for the AcQMap system and what is its clearance number?
The AcQMap High Resolution Imaging and Mapping System was authorized under FDA 510(k) clearance with clearance number K212345 and was determined to be substantially equivalent to a predicate device under product code DQK.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cardiac mapping system - AcQMap® - Acutus Medical - ultrasound, Acutus Medical AcQMap 900100 Operator's Manual, AcQMap - Acutus Medical - PDF Catalogs | Technical Documentation, Access catheter - AcQMap® - Acutus Medical - mapping / ultrasound / cardiac
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212345 | Class II | Active |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
Sources (1)
- FDA 510(k) K212345 24 fields · synced Oct 6, 2026