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510(k) Data Aggregation
K Number
K211546Device Name
Vektor Computational ECG Mapping System (vMap)
Manufacturer
Date Cleared
2021-11-09
(174 days)
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
Vektor Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Vektor Computational ECG Mapping System (vMap™) is intended for the analysis, display, and storage of cardiac electrophysiological data and maps for analysis by a physician.
Device Description
The Vektor Computational ECG Mapping System (vMap™) is a non-invasive software-driven tool for beat-by-beat, multi-chamber, two-dimensional ("2D") and three-dimensional ("3D") analysis and mapping of the heart. vMap" analyzes standard, 12-lead electrocardiographic signals acquired non-invasively from the body surface. vMap™ uses this data to provide various 2D cardiac information and interactive 3D color maps, including cardiac electrical features for analysis by a physician. vMap™ can be used in the clinical environment, such as the electrophysiology ("EP") lab, and in a hospital environment.
The vMap™ System consists of three key components:
1. The vMap™ Software, which drives vMap™ and its core analysis functionalities;
2. The vMap™ Hardware, the computer workstation which facilitates the use of the vMap™ Software; and
3. The vMap™ Disposables, which includes a "Mapping Key" that serves as a license mechanism for the software. Commercial off-the-shelf components such as a USB flash drive and a set of FDA-cleared ECG leads are provided for the physician's convenience.
The electrocardiogram (ECG) signals are displayed and used in proprietary algorithms to transform the measured body surface signals into cardiac signals. vMap™ provides information directly to the physician to help assess patients exhibiting abnormal heart rhythmias). vMap" provides this information by analyzing electrocardiographic information with reference to an arrhythmia-specific cardiac voltage library.
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