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510(k) Data Aggregation

    K Number
    K180027
    Device Name
    ACCUSYTE 3D Fiducial Marker
    Manufacturer
    Radiation Products LLC
    Date Cleared
    2018-07-18

    (196 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiation Products LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed. In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.
    Device Description
    The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle. The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.
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