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510(k) Data Aggregation

    K Number
    K020971
    Device Name
    DCM 2.0
    Manufacturer
    MDS NORDION AB
    Date Cleared
    2002-06-06

    (72 days)

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

    MDS NORDION AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module is used to plan radiation treatment with: - Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV - Cobalt-60 units . DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
    Device Description
    DCM 2.0 is intended for calculations of dose plans, the calculations are based on DICOM objects and other information conveyed by a control communication protocol from the THERAPLAN treatment planning system. DCM is a three-dimensional radiotherapy dose engine for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. Based on quality assured radiation therapy input data Dose Calculation Module (DCM) is used to plan radiation treatment with: - Linear accelerators with X-ray energies from 4 to 50MV and electron energies from 6 . to 25 MeV - . Cobalt-60 units DCM will calculate dose for 3D radiotherapy treatment approaches of combined modality plans, asymmetric and non-coplanar fields; total body irradiation; multi-leaf collimators; motorized and dynamic wedges; customized blocking and bolus.
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