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510(k) Data Aggregation

    K Number
    K222112
    Device Name
    Comfort Marker 2.0
    Date Cleared
    2023-03-30

    (255 days)

    Product Code
    Regulation Number
    892.5785
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.
    Device Description
    Comfort Marker 2.0 is an application system for placing reference marks on patients eligible for Radiotherapy treatments. The Comfort Marker 2.0 allows the user to place accurate tattoo markers (reference points) on patients enabling radio therapy. The device consists of a Control and Pen module which drives a Safety Needle. Different depth settings can be chosen to accommodate for different skin types. When the tattoo marking has been placed the Control Unit can be stored and charged in the Docking station.
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    K Number
    DEN200041
    Device Name
    Comfort Marker 2.0.
    Date Cleared
    2021-12-10

    (536 days)

    Product Code
    Regulation Number
    892.5785
    Why did this record match?
    Product Code :

    QRN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.
    Device Description
    The Comfort Marker 2.0 is an application system for placing reference marks on or in patient's skin to facilitate set-up for radiation therapy treatment. The device includes the following components: - 1. Battery powered control unit with pen - 2. Main powered docking station with adapter and - 3. Safety needle (single use, sterile) Mode of operation: To achieve the intended use, the device uses a safety needle (shown in figure 2). This actuation is achieved by a longitudinal movement of the driving rod inside the pen. The driving mechanism comprises electromagnetic coils, switched on and off by the controller for generating magnetic fields. Hereby, the distance moved by the driving rod can be controlled precisely by controlling the amount of applied energy. The driving device comprises a guiding mechanism arranged for allowing only movement of the driving rod along the longitudinal direction. The actual distance travel is measured with a measuring coil and used to control the desired depth setting. The system contains a mechanical end stop in the safety needle to ensure that the needle will not protrude more than 1 mm. The docking station is used to recharge the control unit.
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