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510(k) Data Aggregation

    K Number
    K961105
    Device Name
    SKIN DOSE MONITOR
    Manufacturer
    Date Cleared
    1996-09-05

    (169 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCMAHON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Although intended primarily for use during Radiological Interventional and Special Procedures, the Skin Dose Monitor can be used whenever there is an interest in knowing patient skin dose. . The primary purpose of the product is to monitor beam entry skin dose within the radiation beam, where there may be a risk of skin burns or cancers dur to extremely high doses. In these situations the beam direction is fixed for a major part of the procedure and the sensor siting is obvious. If the Skin Dose Monitor is to be used for other applications such as dose monitoring of a pregnant woman during general radiological procedures or monitoring doses during fluoroscopic guided surgery, the sensor site may be less obvious. Under these circumstances the sensor might be mounted on the X-Ray collimator face. The real time display of dose may be used to indicate the need to take action to avoid excessive dose to one area of skin by changing the beam direction. The rate indicating LED provides a means to take action which will keep dosage per minute during fluoroscopy at the minimum level needed to ensure acceptable images. The Skin Dose Monitor is also an effective tool for use during staff training or when benchmark protocols are being established for new procedures. Contra indications for use are when the radiation energy or doserate being used fall outside the Skin Dose Monitor's specification, or where the small artefact he image (1 sq. mm), due to the sensor, is unacceptable. f attention is drawn to the user for the need to gas sterilize sensors between applications in accordance with local infection control practice.
    Device Description
    Skin Dose Monitor consists of the model 104–101 The Instrument complete with couch mounting bracket and QA Test Box. The 120 limited re-use sensor is also part of the system. The sensor consists of a scintillating crystal which partially converts absorbed ionizing radiation into visible light. A length of radio translucent optical fiber transports the emitted light to the 104-101 instrument. The light is converted to an electrical current within the instrument and following scaling and integrating, is displayed on an LCD display in Grays or Rads. The instrument is battery powered and the displayed reading is retained when power is switched off.
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