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510(k) Data Aggregation

    K Number
    K973787
    Device Name
    MEDRAD 1.5T EXTREMITY ARRAY
    Manufacturer
    MEDRAD, INC.
    Date Cleared
    1997-12-30

    (85 days)

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

    The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.

    Device Description

    The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, or training set information.

    The document is a 510(k) clearance letter from the FDA for a medical device (MEDRAD 1.5T Extremity Array) and specifies its intended use and regulatory classification. It does not include the technical study details typically found in a clinical study report or a detailed submission document that would outline performance metrics and their validation.

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