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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical Precision BV

    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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