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Found 3 results
510(k) Data Aggregation
K Number
K162440Device Name
CardioInsight Cardiac Mapping System
Manufacturer
CARDIOINSIGHT TECHNOLOGIES, INC
Date Cleared
2016-11-04
(65 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
CARDIOINSIGHT TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medtronic CardioInsight® Cardiac Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Device Description
The Medtronic CardioInsight® Cardiac Mapping System is a non-invasive mapping system for beat-by-beat, multichamber, 3D mapping of the heart. The CardioInsight Cardiac Mapping System displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECG signals in concert with the CT scan information (geometrical information) are used in mathematical algorithms to transform the measured body surface signals into epicardial signals via solving the cardiac inverse problem. The CardioInsight Cardiac Mapping System software uses this data to provide various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The CardioInsight Cardiac Mapping System system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
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K Number
K150990Device Name
ECVUE Mapping System
Manufacturer
CardioInsight Technologies, Inc.
Date Cleared
2015-07-02
(78 days)
Product Code
DQK, DOK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
CardioInsight Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioInsight ECVUE Mapping System is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.
Device Description
ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The system displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
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K Number
K140497Device Name
ECVUE MAPPING SYSTEM
Manufacturer
CARDIOINSIGHT TECHNOLOGIES, INC
Date Cleared
2014-11-19
(265 days)
Product Code
DQK, DOK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
CARDIOINSIGHT TECHNOLOGIES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioInsight ECVUE Mapping System is intended for acquisition, and storage of cardiac electrophysiological data and maps for analysis by a physician.
Device Description
ECVUE is a non-invasive mapping system for beat-by-beat, multi-chamber, 3D mapping of the heart. The system displays cardiac maps and virtual electrograms from real-time chest ECG signals (measured by a Sensor Array placed on the torso) and CT scan data. The ECVUE software provides various cardiac signal analyses and displays interactive 3D color maps including potential, activation, voltage, propagation, and phase maps. The system is mobile and can be used for mapping at the patient's bedside or in the EP lab.
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