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Commissioning Data Management System Cdms
D3 Radiation Planning
Summary: The Commissioning Data Management System (CDMS) by D3 Radiation Planning is a Class 2 medical device used for managing data in radiation therapy settings. It is primarily used by radiation oncologists and medical physicists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K082606 ↗
Decision Date ?
November 10, 2008
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The CDMS was cleared via the FDA 510k pathway on November 10, 2008. It is manufactured by D3 Radiation Planning and classified as a Class 2 device under product code MUJ.
What It Is
The Commissioning Data Management System (CDMS) is a software tool designed to streamline the management of data related to radiation therapy. It assists clinicians in organizing and analyzing data for the commissioning and quality assurance of radiation therapy equipment. This system ensures that radiation doses are accurately calculated and delivered, enhancing the safety and effectiveness of cancer treatments.
FDA-Cleared Indications
- Management of data associated with radiation-therapy equipment commissioning.
- Analysis of radiation-therapy equipment data for dose calculation and treatment-planning support.
- Support of quality-assurance activities for radiation-therapy equipment.
Clinical Applications
- Commissioning newly installed radiation-therapy equipment.
- Organizing and reviewing beam and dose-measurement data.
- Supporting verification of treatment-planning system dose calculations.
- Performing ongoing quality-assurance data review for radiation-therapy systems.
Practical Considerations
- CDMS is software rather than an implanted, wearable, or patient-contact device; it has no physical size or vessel-access requirements.
- Compatibility with the radiation-therapy equipment, treatment-planning system, measurement devices, operating system, and data formats should be confirmed before implementation.
- The system should be configured, validated, and maintained according to the facility’s medical-physics quality-assurance program.
- Because it supports radiation-dose and equipment-performance workflows, data-entry errors, incorrect configuration, or unverified software changes can affect clinical decision-making.
- MRI safety labeling is generally not applicable to software itself, although connected hardware and measurement equipment may have separate MRI safety requirements.
Related Literature
The linked study, 'Generating Team-Based Strategies to Reduce Health Inequity in Cancer Care,' explores how interprofessional care teams can inadvertently perpetuate health disparities. It highlights the significant racial disparities in cancer care, particularly among Black patients with multiple myeloma. The study underscores the need for equity-focused strategies to improve access to care and treatment outcomes. However, it is limited by its focus on a specific patient population and may not address all factors contributing to health inequity.
Frequently Asked Questions
What is the Commissioning Data Management System CDMS used for?
CDMS is used for managing and analyzing data related to radiation therapy equipment to ensure accurate dose calculations and equipment performance.
What specialties typically use this device?
Radiation oncologists and medical physicists typically use CDMS in radiation oncology departments.
What are the FDA-cleared indications?
CDMS is indicated for use in managing data for radiation therapy equipment commissioning and quality assurance to ensure accurate dose delivery.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.