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510(k) Data Aggregation

    K Number
    K232738
    Device Name
    BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
    Manufacturer
    PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla
    Date Cleared
    2024-05-31

    (267 days)

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

    PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeamDose is a software for the following purposes in radiotherapy: - absolute dose measurements as field class dosemeter (according to IEC 60731) - monitor calibration - positioning of detectors in PTW water phantoms The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731. The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results. Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom. The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel. The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
    Device Description
    The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values. The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms. The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters. The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor. The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
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