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Vektor Computational ECG Mapping System (vMap)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K211546

by Vektor Medical, Inc.

Identifiers

510(k) Number
K211546 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 Vektor Computational ECG Mapping System (vMap) is a Cardiac Electrophysiology Mapping Device designed for the analysis, display, and storage of cardiac electrophysiological data. It employs computational algorithms to generate detailed maps of electrical activity in the heart, aiding in the identification of arrhythmia sources, including focal and fibrillation-type abnormalities.

This system is intended for use in clinical settings by physicians to enhance diagnostic accuracy and procedural planning for cardiac ablation. Supplied as a software-based solution, it requires integration with compatible ECG devices and does not require sterilisation or single-use disposal. The device holds FDA 510(k) clearance and MDR authorization, ensuring compliance with regulatory standards for cardiovascular diagnostic tools.

Frequently asked questions

What clinical scenarios is the vMap system primarily designed to assist with during cardiac procedures?

The vMap system is designed to aid in identifying sources of arrhythmias, such as focal abnormalities and fibrillation-type issues, by generating detailed computational maps of electrical heart activity. Clinicians use it to improve diagnostic accuracy and guide procedural planning for cardiac ablation, helping to pinpoint precise treatment targets during interventions.

How is the vMap system supplied, and does it require sterilization or single-use disposal?

The vMap is supplied as a software-based solution that integrates with compatible ECG devices. Since it is not a physical implantable or disposable device, it does not require sterilization or single-use disposal. It operates as a reusable clinical tool in settings where ECG data is captured and analyzed.

What regulatory pathways has the vMap system undergone, and what does that mean for its use?

The vMap system holds both FDA 510(k) clearance and MDR authorization, confirming compliance with U.S. and European regulatory standards for cardiovascular diagnostic devices. This means it has been evaluated for safety and performance by regulatory bodies, ensuring it meets established criteria for use in clinical settings as described in its intended purpose.

Is the vMap system compatible with any specific types of ECG devices, or does it require integration with particular hardware?

The vMap system is designed as a software solution that requires integration with compatible ECG devices to function. While the exact compatible hardware isn’t detailed here, its purpose relies on capturing ECG data from existing clinical systems to generate detailed computational maps for analysis.

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: vMap | Vektor Medical, Vektor Medical, Vektor Computational ECG Mapping System (vMap®), Vektor Computational ECG Mapping System (vMap®) (K252429)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vektor Medical, Inc.

Sources (2)

  • FDA 510(k) K211546 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026