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510(k) Data Aggregation

    K Number
    K993962
    Device Name
    PENSIL TRAUMA, MODEL WWS6100
    Manufacturer
    WUESTEC MEDICAL, INC.
    Date Cleared
    1999-12-21

    (57 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PENSIL TRAUMA, MODEL WWS6100

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

    The Pensil Trauma is a wall-mounted radiographic cassette holder device that is a 1110 Total Tradition 10 and position radiographic cassettes for a radiographic exposure for medical use.

    Device Description

    The Pensil Trauma is a wall-mounted radiographic cassette holder device.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and study proving device performance. The document is an FDA 510(k) clearance letter for the "Pensil Trauma, Model WW56100" device, identifying it as a wall-mounted radiographic cassette holder.

    While it mentions the device is "substantially equivalent" to legally marketed predicate devices, it does not include any specific performance metrics, acceptance criteria, or details regarding studies (sample sizes, ground truth, expert qualifications, etc.) that would prove the device meets such criteria.

    The letter focuses on regulatory approval based on substantial equivalence, general controls, and compliance with manufacturing practices, rather than providing a technical performance evaluation.

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