đź“‹ FDA Reference
explorer 4d treatment planning system
American Radiosurgery
Summary: The Explorer 4D Treatment Planning System is a medical device used for planning radiation therapy treatments. It is primarily used by radiation oncologists and medical physicists to optimize treatment plans for patients undergoing radiation therapy.
FDA Clearance Information
Pathway 510K
Number K101220 ↗
Decision Date November 5, 2010
Product Code MUJ
Device Class Class 2
Evidence 0 studies
The Explorer 4D Treatment Planning System was cleared through the FDA 510k pathway on November 5, 2010. Manufactured by American Radiosurgery, it is classified as a Class 2 device under product code MUJ.
What It Is
The Explorer 4D Treatment Planning System is a sophisticated software tool designed to assist in the planning of radiation therapy for cancer patients. It utilizes advanced algorithms to optimize the delivery of radiation doses, taking into account the movement of tumors and surrounding tissues over time. This allows for precise targeting of cancerous cells while minimizing exposure to healthy tissues.
Clinical Applications
This system is commonly used in oncology settings, particularly in hospitals and cancer treatment centers. It is essential for creating personalized radiation therapy plans for patients with various types of cancer, including those affecting the lungs, prostate, and brain. The system is used by radiation oncologists and medical physicists to ensure that treatment plans are both effective and safe.
Indications for Use
The Explorer 4D Treatment Planning System is indicated for use in planning radiation therapy treatments. It is particularly useful for patients with tumors that may move during treatment, such as those in the lungs or abdomen, allowing for more accurate targeting of radiation.
Practical Considerations
The system is compatible with various radiation delivery systems and can be integrated into existing clinical workflows. Clinicians should be trained in its use to fully leverage its capabilities, and regular updates may be required to maintain optimal performance.
Related Literature
The linked study discusses the RayStation treatment planning system, highlighting its advanced features such as multiatlas based autosegmentation and 4D adaptive radiation therapy. Key findings include its ability to plan for different radiation modalities and its application in clinical cases. However, the study primarily focuses on RayStation, and direct comparisons to the Explorer 4D system are not provided.
Frequently Asked Questions
What is the Explorer 4D Treatment Planning System used for?
It is used for planning and optimizing radiation therapy treatments for cancer patients.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology settings.
What are the FDA-cleared indications?
The device is indicated for planning radiation therapy, especially for tumors that may move during 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.