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510(k) Data Aggregation

    K Number
    K023293
    Device Name
    MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02
    Manufacturer
    MED-TEC,INC.
    Date Cleared
    2002-12-23

    (82 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02

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

    The intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area. The belly board can be used by it's self or with MED-TEC's HipFix system. The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Bellyboard," stating that it has been found substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, but no performance studies or acceptance criteria are detailed.

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