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510(k) Data Aggregation

    K Number
    K192196
    Device Name
    Medical Radiation Dosimetry System microSTARii
    Manufacturer
    Date Cleared
    2019-12-27

    (136 days)

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

    Landauer

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LANDAUER® microSTAR®ii Medical Dosimetry System provides an accurate, reliable and easy-to-use dosimeter and reader intended for use in measuring dose on-phantom or on-patient in medical dosimetry applications, such as radiotherapy and diagnostic radiology. When used to measure patient dose, the system is used to provide a secondary verification of radiation dose as a means of Quality Control for the primary dose calculation method. The output of the microSTAR®ii system is not used to adjust the dose to the patient.
    Device Description
    The LANDAUER® microSTARii Medical Dosimetry System consists of the following components to provide secondary verification of dose from various radiotherapy and diagnostic imaging devices: Dosimeter (nanoDot) to record radiation during radiation exposure. Reading device (microSTARii Reader) for reading the radiation dose recorded by the dosimeter. microSTARii Software Application, a simple software tool that the user interacts with for radiation dose calculation, dose reporting, managing and storing data. 2D barcode scanner. Calibration Dosimeter Set (nanoDots) for QC/Calibration.
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