Viewray Treatment Planning and Delivery System

FDA-Cleared Indications

• Radiation treatment planning and delivery for patients requiring radiotherapy.
• Use of MRI guidance to support localization and targeting of treatment areas.
• Treatment of malignant tumors in anatomical regions that can be imaged and treated by the system.

Clinical Applications

• MRI-guided external-beam radiotherapy planning.
• MRI-guided radiation treatment delivery for malignant tumors.
• Image-guided targeting and monitoring during radiotherapy.
• Adaptive radiotherapy planning when tumor position or nearby anatomy changes during treatment.

Reported off-label uses

• MRI-guided stereotactic or hypofractionated treatment protocols in selected patients.
• MRI-guided treatment of prostate cancer and spine metastases when performed under an institutionally approved protocol.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system combines an MRI scanner with a radiation-delivery system; treatment requires staff trained in both MRI safety and radiotherapy.
• MRI-related contraindications and precautions apply, including certain implanted devices, metallic foreign bodies, and inability to remain still or follow breath-hold instructions.
• Treatment planning must account for magnetic-field effects, patient positioning, imaging artifacts, and the compatibility of immobilization equipment and accessories.
• The treatment field, patient size, and ability to position the target within the system can limit which tumors can be treated.
• Treatment duration and the number of sessions vary with the cancer, prescribed radiation dose, imaging requirements, and whether adaptive replanning is needed.