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4d integrated treatment console
Varian Medical Systems
Summary: The 4d integrated treatment console by Varian Medical Systems is a Class 2 medical device used in radiation therapy. It is designed for use by radiation oncologists and medical physicists to enhance treatment precision.
FDA Clearance Information
Pathway
510K
Number
K203766 ↗
Decision Date
February 12, 2021
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The 4d integrated treatment console was cleared through the FDA 510(k) pathway on February 12, 2021. Manufactured by Varian Medical Systems, it is classified as a Class 2 device under product code MUJ.
What It Is
The 4d integrated treatment console is a sophisticated device used in radiation therapy to improve the precision and effectiveness of treatment delivery. It integrates imaging and treatment capabilities, allowing clinicians to visualize and adjust treatment in real-time. This integration helps in targeting tumors more accurately while sparing healthy tissue.
Clinical Applications
This device is commonly used in oncology settings, particularly in radiation therapy departments. It is utilized by radiation oncologists and medical physicists to treat various types of cancer, including those requiring precise targeting like brain, prostate, and head and neck cancers. The console's advanced imaging capabilities make it suitable for complex cases where tumor motion needs to be accounted for.
Indications for Use
The 4d integrated treatment console is indicated for use in patients undergoing radiation therapy, particularly those requiring precise targeting of tumors. It is suitable for conditions where real-time imaging can enhance treatment accuracy and outcomes.
Practical Considerations
The device is typically integrated into existing radiation therapy systems and requires compatibility with specific imaging and treatment technologies. Clinicians should be trained in its operation to maximize its benefits, and regular maintenance is essential to ensure optimal performance.
Related Literature
The linked study explored the integration of magnetic resonance imaging with a radiation therapy source, demonstrating the feasibility of obtaining MR images during megavoltage photon irradiation. Key findings included successful resolution of mutual interferences between the MR system and the linac, allowing for concurrent imaging and treatment. Limitations include the study's prototype nature and the need for further research to validate clinical applications.
Frequently Asked Questions
What is the 4d integrated treatment console used for?
It is used to enhance the precision of radiation therapy by integrating imaging and treatment capabilities.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology settings use this device.
What are the FDA-cleared indications?
The device is indicated for use in radiation therapy, particularly for precise targeting of tumors in patients.
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.