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510(k) Data Aggregation

    K Number
    K041971
    Device Name
    WIMRT MODULE FOR ARTP PLANNING SYSTEM
    Manufacturer
    PRODIGM GROUP, INC.
    Date Cleared
    2005-05-20

    (302 days)

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

    PRODIGM GROUP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
    Device Description
    The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
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