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510(k) Data Aggregation

    K Number
    K152184
    Device Name
    MagView BIOMAGNETOMETER SYSTEM
    Manufacturer
    TRISTAN TECHNOLOGIES, INC
    Date Cleared
    2016-04-08

    (247 days)

    Product Code
    OLY
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRISTAN TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the Mag View Biomagnetometer is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the sources of those magnetic fields could contribute to diagnosis or therapy planning. The intended patient populations are neonates and those children with head circumferences of 50 cm or less.
    Device Description
    The Tristan Technologies MagView Biomagnetometer (hereinafter referred to as the "MagView") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The MagView consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SOUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
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    K Number
    K151135
    Device Name
    MODEL 621/624 BIOMAGNETOMETER
    Manufacturer
    TRISTAN TECHNOLOGIES, INC
    Date Cleared
    2016-03-15

    (321 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRISTAN TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tristan Technologies Model 621/624 Biomagnetometer is intended for use as a tool that noninvasively measures and displays the magnetic signals produced by the electric currents in the heart of human beings of any age or in the heart of a fetus in utero.
    Device Description
    The Tristan Technologies Model 621/624 Biomagnetometer (hereinafter referred to as the "Model 621/624") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in the heart. The Model 621/624 consists of a sensor unit, an electronics subsystem for preliminary amplification, filtering, and analog to digital conversion of the signals from each SQUID, an electronics rack containing power supplies to power the electronics subsystem, a computer to control the operation of the electronic subsystem and the SQUIDs and to acquire and store the signal values collected by the system.
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