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510(k) Data Aggregation
K Number
K182571Device Name
CardioFlux with Faraday Analytical Cloud
Manufacturer
Date Cleared
2019-03-15
(178 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Genetesis Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CardioFlux FAC Magnetocardiograph is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.
Device Description
The CardioFlux FAC Magnetocardiograph (MCG) is a biomagnetic sensing device that can record and display the magnetic fields generated by cardiac electrical activity. The CardioFlux FAC hardware connects to the Faraday™ Analytical Cloud (FAC) to allow access to a patient database and software for data analysis. The CardioFlux FAC MCG system consists of a patient table, a 6 x 6 array of optically pumped magnetometers covering roughly an area of 400 square centimeters and a shielding cylinder to reduce ambient electromagnetic interference during a patient scan. CardioFlux FAC is primarily controlled via software applications on a local computer. Data are displayed as 36 superimposed cardiocycles and magnetic field maps.
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