AcQMap High Resolution Imaging and Mapping System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231091 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 medical device designed for use in electrophysiology procedures to reconstruct cardiac chamber anatomy from ultrasound data and visualize electrical activity. It is intended to display charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
The system is supplied as a non-sterile, reusable imaging and mapping platform intended for use with AcQMap catheters in clinical electrophysiology settings. It has received FDA 510(k) clearance (K231091) and is authorized for marketing in the United States under product code DQK. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the supplied data.
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: Acutus Medical AcQMap 900100 Operator's Manual, PDF Acutus AcQMap High Resolution Imaging + Mapping System, AcQMap - Acutus Medical - PDF Catalogs | Technical Documentation, Acutus Medical AcQMap 900100 Operator's Manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231091 | Class II | Active |
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Manufacturer
- Manufacturer
- Acutus Medical, Inc.
Sources (1)
- FDA 510(k) K231091 24 fields · synced Oct 6, 2026