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510(k) Data Aggregation

    K Number
    K023613
    Device Name
    AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
    Manufacturer
    ALPHATEK CORP.
    Date Cleared
    2003-01-23

    (87 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHATEK CORP.

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

    THE Ax200 is intended to develop medical x-ray film.

    Device Description

    AX200 Automatic X-Ray Film Processor Model # 6586.03

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding an automatic x-ray film processor (AX200, Model #6586.03). This type of document confirms that the device is substantially equivalent to a legally marketed predicate device and allows it to be marketed.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in the prompt regarding the performance of the device.

    The letter focuses solely on the regulatory approval process and does not delve into the technical validation or clinical study results that would typically include the requested information.

    Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based on the given input.

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