đź“‹ FDA Reference
4d integrated treatment console
Varian Medical Systems
Summary: The 4d integrated treatment console by Varian Medical Systems is a Class 2 medical device used primarily in radiation therapy settings. It is designed for use by oncology specialists to enhance precision in treatment delivery.
FDA Clearance Information
Pathway
510K
Number
K133331 ↗
Decision Date
January 27, 2014
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The 4d integrated treatment console was cleared through the FDA 510(k) pathway on January 27, 2014, 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 synchronize imaging and treatment delivery. It integrates advanced imaging technologies with a linear accelerator to allow for precise targeting of tumors while minimizing exposure to surrounding healthy tissues. This integration is crucial for adaptive radiation therapy, where real-time imaging guides adjustments during treatment sessions.
Clinical Applications
This device is commonly used in oncology departments, particularly in hospitals and specialized cancer treatment centers. It is essential for treating various cancers, including those in the brain, prostate, and lungs, where precision is critical. Radiation oncologists and medical physicists use it to plan and deliver treatments that require high accuracy and adaptability to patient movements.
Indications for Use
The FDA indications suggest that this device is intended for use in radiation therapy to improve the precision of treatment delivery. It is suitable for patients requiring targeted radiation, such as those with tumors in sensitive or hard-to-reach areas.
Practical Considerations
The 4d integrated treatment console requires compatibility with existing linear accelerators and imaging systems. Clinicians should ensure proper calibration and integration with other devices to optimize its functionality. Regular maintenance and software updates are essential to maintain accuracy and safety.
Related Literature
The linked study explored the feasibility of integrating magnetic resonance imaging with a linear accelerator for radiation therapy. The study demonstrated that MR images could be obtained during megavoltage photon irradiation without interference between the systems. While promising, the study was limited by its prototype nature and the need for further research to validate the findings in clinical settings.
Frequently Asked Questions
What is 4d integrated treatment console used for?
It is used in radiation therapy to enhance precision in targeting tumors while minimizing exposure to healthy tissues.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology departments and cancer treatment centers.
What are the FDA-cleared indications?
The device is indicated for improving precision in radiation therapy for patients requiring targeted treatment.
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.