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rt elements cranial srs spine srs multiple brain mets srs rt qa adaptive hybrid surgery analysis dose review
Brainlab Ag
Summary: The rt elements cranial SRS by Brainlab Ag is a medical device used in stereotactic radiosurgery (SRS) for treating cranial and spinal conditions, including multiple brain metastases. It is primarily used by radiation oncologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K190664 ↗
Decision Date
April 12, 2019
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
This device was cleared through the FDA 510(k) pathway on April 12, 2019, 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 software-based medical device designed to assist in stereotactic radiosurgery, a non-invasive procedure that delivers precise, high-dose radiation to targeted areas in the brain and spine. It integrates with existing imaging and treatment planning systems to enhance accuracy and efficiency in treatment delivery. The device supports adaptive planning and dose review, allowing for personalized treatment adjustments.
Clinical Applications
This device is commonly used in the treatment of brain and spine tumors, including multiple brain metastases, where precise targeting of radiation is crucial. It is utilized in both hospital and outpatient settings, primarily by specialists in radiation oncology and neurosurgery. The device is suitable for adult and pediatric patients requiring high-precision radiation therapy.
Indications for Use
The device is intended for use in patients requiring stereotactic radiosurgery for cranial and spinal conditions, particularly those with multiple brain metastases. It is designed to enhance treatment precision and adaptability.
Practical Considerations
The device is compatible with various imaging modalities and treatment planning systems, facilitating integration into existing clinical workflows. Clinicians should ensure proper training in its use to maximize treatment accuracy and safety.
Frequently Asked Questions
What is rt elements cranial srs used for?
It is used for stereotactic radiosurgery to treat cranial and spinal conditions, including multiple brain metastases.
What specialties typically use this device?
Radiation oncologists and neurosurgeons primarily use this device.
What are the FDA-cleared indications?
The device is indicated for stereotactic radiosurgery in cranial and spinal conditions, focusing on precise radiation delivery for multiple brain metastases.
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.