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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 ?
510(k)
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.
FDA-Cleared Indications
- Used for planning radiation therapy treatments.
- Used to support the creation and optimization of radiation treatment plans for patients with cancer.
Clinical Applications
- Planning external-beam radiation therapy treatments.
- Optimizing radiation dose distributions for individualized cancer treatment plans.
- Supporting treatment planning when tumor or nearby tissue position changes during the treatment process.
- Helping radiation oncologists and medical physicists evaluate planned radiation delivery before treatment.
Practical Considerations
- The system is treatment-planning software; it does not deliver radiation and must be used with compatible radiation therapy equipment.
- Use requires trained radiation oncology professionals, typically including a radiation oncologist and medical physicist.
- Clinical teams should verify image sets, patient positioning, contours, treatment constraints and calculated dose before approving a plan.
- MRI safety applies to the imaging equipment and accessories used to acquire patient data, not to the planning software itself. MRI compatibility should be confirmed for each scanner, accessory and workflow.
- Software updates, validation testing and integration checks may be needed to maintain compatibility with imaging and radiation delivery systems.
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.