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510(k) Data Aggregation

    K Number
    K133419
    Device Name
    BABYMEG BIOMAGNETOMETER SYSTEM
    Manufacturer
    TRISTAN TECHNOLOGIES INC
    Date Cleared
    2014-07-21

    (256 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 Artemis 123 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 location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.
    Device Description
    The Tristan Technologies Artemis 123 Biomagnetometer (hereinafter referred to as the "Artemis 123") utilizes superconducting signal pickup coils and Superconducting Quantum Interference Devices (SQUIDs) to detect and amplify magnetic fields produced by electrical activity in brain. The Artemis 123 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, and a patient table which accommodates and facilitates the optimal positioning of the head of a human being adjacent to the sensor unit.
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