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510(k) Data Aggregation

    K Number
    K983918
    Device Name
    RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)
    Manufacturer
    MASTEK, INC.
    Date Cleared
    1999-03-12

    (128 days)

    Product Code
    IXA
    Regulation Number
    892.1850
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. The R-CLIP positions and secures limbs for radiographic x-ray exposure.
    2. The R-CLIP provides vertical and horizontal limb positioning relative to plane of radiographic view.
    3. The R-CLIP avoids x-ray exposure to surgical staff by eliminating the need to hold the limb during exposure.
    4. The R-CLIP is reusable and autoclavable. The R-CLIP Retainer kit is sterile, single use only.
    Device Description

    Radiolucent Cassette LIMB Positioner (R-Clip)

    AI/ML Overview

    This is a 510(k) clearance letter for a device called "Radiolucent Cassette LIMB Positioner (R-Clip)". The letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, the provided documents do not contain information about the device's acceptance criteria or any study that proves the device meets those criteria.

    The documents are a regulatory clearance letter and a description of the device's intended use. They do not detail the technical performance or testing conducted to support the substantial equivalence claim.

    Therefore, I cannot provide the requested information.

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