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510(k) Data Aggregation

    K Number
    K991435
    Device Name
    AII-PRO 100 PLUS AND ALL-PRO 200
    Manufacturer
    ALL-PRO IMAGING CORP.
    Date Cleared
    1999-05-20

    (24 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The All-Pro 100 Plus and All-Pro 200 are automatic x-ray film processors. They develop, fix, wash and dry medical x-ray film. Properly processed x-ray films are available for reading by medical practitioners more rapidly and with more consistency than with manual processing.

    Device Description

    automatic x-ray film processors

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth used, or training set details.

    The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the All-Pro 100 Plus and All-Pro 200 x-ray film processors. This letter indicates that the devices have been found substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not contain any technical details about performance studies or acceptance criteria.

    To answer your request, I would need a different document that details the testing and validation of the device.

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