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510(k) Data Aggregation
K Number
K020971Device Name
DCM 2.0
Manufacturer
MDS NORDION AB
Date Cleared
2002-06-06
(72 days)
Product Code
MUJ
Regulation Number
892.5050Why 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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