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510(k) Data Aggregation

    K Number
    K133959
    Device Name
    PODIATRY X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2015-01-22

    (394 days)

    Product Code
    KPR,MQB
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Model PXS-710D X-Ray System is intended for General Purpose Podiatry Radiographic Applications.

    Device Description

    Not Found

    AI/ML Overview

    This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria for the Podiatry X-Ray System (Model PXS-710D).

    The provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's substantial equivalence to predicate devices but does not include clinical study data, performance metrics, ground truth establishment, or sample sizes related to the device's specific performance.

    Therefore, I cannot provide the requested information based on the input text. The document focuses on regulatory clearance, not on the technical performance study details.

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