đź“‹ FDA Reference
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
510K
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.
Clinical Applications
CDMS is commonly used in radiation oncology departments to support the commissioning of new radiation therapy equipment and ongoing quality assurance processes. It is particularly useful in settings where precise radiation dose calculations are critical, such as in the treatment of complex cancers. The system is used by medical physicists and radiation oncologists to ensure that treatment plans are accurately implemented.
Indications for Use
The FDA indications for CDMS involve its use in the management and analysis of data related to radiation therapy equipment. It is intended for use in ensuring accurate dose calculations and equipment performance, which is crucial for patient safety and effective treatment outcomes.
Practical Considerations
CDMS is typically compatible with a range of radiation therapy equipment and software systems. Clinicians should ensure that their existing systems are compatible with CDMS to maximize its utility. Regular updates and maintenance may be required to keep the system functioning optimally.
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.