📋 FDA Reference
Monaco Rtp System
Elekta Solutions Ab
Summary: The Monaco RTP System is a radiation treatment planning system used by oncologists for precise dose calculations in cancer therapy. It is designed to enhance treatment accuracy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202789 ↗
Decision Date ?
February 23, 2021
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Monaco RTP System was cleared through the FDA 510(k) pathway on February 23, 2021. Manufactured by Elekta Solutions Ab, it is classified as a Class 2 device under product code MUJ.
What It Is
The Monaco RTP System is a sophisticated radiation treatment planning system that utilizes advanced algorithms, including Monte Carlo simulations, to calculate radiation doses for cancer patients. This system is integral in developing precise treatment plans that optimize the delivery of radiation therapy, minimizing exposure to healthy tissues while targeting cancerous cells.
FDA-Cleared Indications
- Planning radiation therapy treatments for patients with cancer.
- Calculating and optimizing radiation dose distributions for radiation treatment planning.
Clinical Applications
- Creating computer-based radiation treatment plans from patient imaging and anatomy.
- Calculating radiation dose distributions for external-beam radiation therapy.
- Optimizing treatment plans to deliver the prescribed dose to a tumor while reducing dose to surrounding normal tissue.
- Supporting radiation oncology treatment planning by oncologists, medical physicists, and dosimetrists.
Practical Considerations
- The system must be compatible with the treatment machines, imaging systems, oncology information systems, and dose-delivery workflows used by the treatment facility.
- Treatment plans require review and approval by qualified radiation oncologists and medical physicists before radiation is delivered.
- Monte Carlo and other advanced dose-calculation methods may require additional computing resources and quality-assurance procedures.
- The system is software rather than an implanted or patient-contact device; it has no physical patient size range, vascular access requirement, or MRI safety designation.
- Software version control, cybersecurity, user training, backups, and routine radiation-treatment quality assurance are important for safe operation.
Related Literature
The linked study explored the use of Monte Carlo modeling with the Elekta Versa HD for patient dose calculations. It demonstrated that Monte Carlo methods provide accurate dose calculations, even when using open-source software. However, the study noted that not all clinics have access to commercial Monte Carlo treatment planning systems, highlighting the need for accessible solutions.
Frequently Asked Questions
What is Monaco RTP System used for?
The Monaco RTP System is used for planning and optimizing radiation therapy treatments for cancer patients, ensuring precise dose delivery.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology departments typically use the Monaco RTP System.
What are the FDA-cleared indications?
The device is cleared for planning radiation therapy treatments to optimize dose delivery to cancerous tissues while minimizing exposure to healthy tissues.
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.