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510(k) Data Aggregation

    K Number
    K980477
    Device Name
    IMAGE VUE EEG
    Manufacturer
    SAM TECHNOLOGY, INC.
    Date Cleared
    1998-08-06

    (181 days)

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

    SAM TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function and structure by fusing a variety of EEG information with MRI images. The software is intended for use by a qualified/trained EEG technologist or physician on the visualization of human brain electrical activity by fusing a variety of Lilit information with MKI images.
    Device Description
    The software imports digital EEG data (in a variety of formats) and MKI data and permits the fusing and viewing of both types of data. No direct intervention, treatment, or on-line monitoring of the patient is performed.
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