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viewray treatment planning and delivery system
Viewray
Summary: The Viewray treatment planning and delivery system is a medical device used for radiotherapy, integrating MRI for precise treatment planning. Key evidence highlights its use in prostate cancer and spine metastases treatment.
FDA Clearance Information
Pathway
510K
Number
K102915 ↗
Decision Date
January 12, 2011
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Viewray treatment planning and delivery system was cleared by the FDA through the 510(k) pathway on January 12, 2011. It is manufactured by Viewray and classified as a Class 2 device under product code MUJ.
What It Is
The Viewray system is a radiotherapy device that combines magnetic resonance imaging (MRI) with radiation delivery for precise treatment planning and execution. It is intended for use in radiotherapy to enhance the accuracy of tumor targeting while minimizing exposure to surrounding healthy tissues.
Clinical Applications
Common clinical scenarios for the Viewray system include treatment of prostate cancer and spine metastases, where precise imaging and adaptive planning are crucial. It is particularly useful in cases requiring hypofractionated radiotherapy schedules.
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2023 to 2025, focusing on various cancer treatments using the Viewray system.
Reported Outcomes
Published studies report that the Viewray system enhances the precision of radiotherapy in prostate cancer and spine metastases, with improved targeting accuracy and potential for reduced treatment times. Outcomes in prostate cancer show promising results with hypofractionated schedules.
Safety Profile
Reported complications include cardiotoxicity in lung cancer patients undergoing thoracic radiotherapy, highlighting the need for careful monitoring of cardiac health. No other significant adverse events were noted in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of large-scale randomized controlled trials and the variability in clinical workflows across different studies. Further research is needed to standardize treatment protocols and assess long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Viewray treatment planning and delivery system?
The Viewray system is indicated for use in radiotherapy, particularly in treating prostate cancer and spine metastases, where precise imaging and adaptive planning are essential.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved targeting accuracy and potential for reduced treatment times in prostate cancer and spine metastases using the Viewray system.
What complications have been reported?
Safety data indicate cardiotoxicity as a complication in lung cancer patients undergoing thoracic radiotherapy, necessitating careful cardiac monitoring.
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.