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510(k) Data Aggregation

    K Number
    K080655
    Device Name
    CHRYSALIS
    Date Cleared
    2008-05-09

    (63 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    META IMAGING SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device described here is an accessory to imaging devices previously approved. In general, the intended professional application is described as follows: Breast displacement for imaging purposes with the intention of decreasing radiation dose to the breasts and/or improving image quality. The Chrysalis device is reusable and used external to hospital garb; it does not touch the patient's body.
    Device Description
    Chrysalis is composed of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, Buckles: 2" side-release plastic buckles
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