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510(k) Data Aggregation

    K Number
    K093503
    Device Name
    INTRAX FILM PROCESSOR
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2010-01-06

    (55 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K874118
    Why did this record match?
    Device Name :

    INTRAX FILM PROCESSOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .

    Device Description

    IntraX Film Processor
    Trade Name: IntraX Film Processor
    Common Name: Automatic Film processor
    Classification name: Processor, Radiographic-Film, Automatic
    Device Class 2
    Regulation Number: 892.1900

    AI/ML Overview

    This is a 510(k) summary for a radiographic film processor, not an AI/ML medical device. Therefore, the information typically requested in questions 1 through 9 (related to acceptance criteria, study design, ground truth, and human-in-the-loop performance for AI/ML devices) is not applicable or present in this document.

    The document describes a traditional medical device (IntraX Film Processor) and its substantial equivalence to predicate devices, focusing on regulatory classification, indications for use, and general controls provisions of the FDA. It does not contain information about AI/ML algorithm performance, test sets, training sets, or expert adjudication that would be used to assess an AI/ML-driven device.

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