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510(k) Data Aggregation

    K Number
    K962933
    Device Name
    OPART MRT-600
    Manufacturer
    TOSHIBA AMERICA MRI, INC.
    Date Cleared
    1996-10-25

    (88 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K981475,K991057,K991740
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy

    Device Description

    The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document describes a Magnetic Resonance Device (OPART™) and compares its safety and imaging performance parameters to two other MR systems (Flexart™ and Visart™).

    Specifically, the text is a 510(k) summary for a medical device (an MRI system), which is focused on demonstrating substantial equivalence to a predicate device rather than on the performance of a software algorithm that would typically have acceptance criteria and a detailed study.

    Therefore, I cannot provide the requested information from the given input.

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