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510(k) Data Aggregation

    K Number
    K110066
    Device Name
    AQUILION PRIME
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Date Cleared
    2012-01-26

    (381 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K093891,k093891
    Predicate For
    K120710
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.

    The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    Device Description

    The TSX-302A is an 80-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A is based upon the technology and materials of previously marketed Toshiba CT systems.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets said criteria. The document is a 510(k) summary for the TSX-302A, Aquilion Prime CT System, detailing its intended use, substantial equivalence to a predicate device, and regulatory information from the FDA. It does not include any performance data or study details.

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