BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇩🇰 Denmark

    BioXmark

    K Number: DEN220017 · Decision Dec 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    294

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    Basic Information

    Device Name
    BioXmark
    K Number
    DEN220017
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    892.5727
    Medical Specialty
    Radiology
    Decision
    Unknown
    Applicant
    Nanovi A/S
    Date Received
    March 4, 2022
    Decision Date
    December 23, 2022
    Product Code
    QUV
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QUV Phase-Changing Fiducial Marker For Radiation Therapy