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510(k) Data Aggregation

    K Number
    K211590
    Device Name
    Fiducial Marker
    Manufacturer
    Carbon Medical Technologies Inc.
    Date Cleared
    2021-06-10

    (17 days)

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

    Carbon Medical Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The [Trade Name] Fiducial Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic body radiosurgery (SBRT) and radiotherapy target localization.
    Device Description
    The [Trade Name] Fiducial Marker is a sterile, pyrogen free, single patient use, pyrolytic carbon coated zirconium oxide discrete marker incorporated into lyophilized glucan gel carrier that is visible on kV X-ray, CT, CBCT, mammography, ultrasound, and Magnetic Resonance Imaging (MRI).
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