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510(k) Data Aggregation

    K Number
    K071392
    Device Name
    PXS-810, PODIATRY X-RAY SYSTEM
    Manufacturer
    SOURCE-RAY, INC.
    Date Cleared
    2007-08-03

    (77 days)

    Product Code
    KPR
    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-810 Podiatry X-Ray System is intended for General Purpose Podiatry Radiographic Applications.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for an X-ray System, Podiatry (Model PXS-810). It states that the device is substantially equivalent to legally marketed predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for that specific information from this document. The letter focuses on the regulatory clearance process and substantial equivalence, not on the detailed technical data or clinical study results that would typically include such details.

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