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rt elements cranial srs w cones multiple brain mets srs cranial srs spine srs rt qa dose review
Brainlab Ag
Summary: The rt elements cranial SRS is a medical device used for stereotactic radiosurgery (SRS) to treat multiple brain metastases and spinal conditions. It is typically used by radiation oncologists and neurosurgeons in specialized medical centers.
FDA Clearance Information
Pathway
510K
Number
K203681 ↗
Decision Date
April 9, 2021
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510k pathway on April 9, 2021, by Brainlab Ag. It is classified as a Class 2 medical device under product code MUJ.
What It Is
The rt elements cranial SRS is a sophisticated tool designed for precise delivery of radiation therapy to brain and spine lesions. It utilizes advanced software algorithms to optimize the treatment plan, ensuring high-dose radiation is accurately targeted to the tumor while sparing surrounding healthy tissue. This device is particularly useful in treating multiple brain metastases and spinal lesions with minimal invasiveness.
Clinical Applications
This device is commonly used in clinical scenarios involving patients with brain metastases or spinal tumors requiring precise radiation treatment. It is predominantly used in oncology settings, particularly in radiation therapy departments of hospitals and specialized cancer treatment centers. The device is suitable for adult patients who require targeted radiation therapy as part of their cancer treatment plan.
Indications for Use
The FDA-cleared indications for this device include treatment of multiple brain metastases and spinal lesions using stereotactic radiosurgery. It is intended for patients who need precise, high-dose radiation therapy to manage their cancerous lesions.
Practical Considerations
Clinicians should ensure compatibility with existing radiation therapy equipment and verify the device's software integration with their treatment planning systems. Proper training on the device's operation and treatment planning is essential for optimal outcomes.
Frequently Asked Questions
What is rt elements cranial SRS used for?
It is used for delivering precise radiation therapy to treat multiple brain metastases and spinal lesions.
What specialties typically use this device?
Radiation oncologists and neurosurgeons typically use this device in oncology and specialized medical centers.
What are the FDA-cleared indications?
The device is indicated for treating multiple brain metastases and spinal lesions using stereotactic radiosurgery.
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.