📋 FDA Reference
Monaco Rtp System
Elekta
Summary: The Monaco RTP System is a radiation treatment planning system used by oncology specialists to calculate precise radiation doses for cancer patients. It is commonly used in radiotherapy clinics.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190178 ↗
Decision Date ?
March 29, 2019
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The Monaco RTP System by Elekta was cleared through the FDA 510(k) pathway on March 29, 2019. It is classified as a Class 2 medical device under product code MUJ.
What It Is
The Monaco RTP System is a sophisticated radiation treatment planning system that utilizes advanced algorithms, including the Monte Carlo method, to calculate radiation doses for cancer treatment. It is designed to optimize the delivery of radiation therapy by accurately modeling the dose distribution within the patient's body. This system is crucial for ensuring that the maximum dose is delivered to the tumor while minimizing exposure to surrounding healthy tissues.
FDA-Cleared Indications
- Used to create radiation treatment plans for patients receiving external-beam radiotherapy.
- Calculates radiation dose distributions using patient imaging and treatment-delivery information.
- Supports planning intended to deliver therapeutic radiation to a target while limiting dose to surrounding tissues.
Clinical Applications
- Planning external-beam radiotherapy treatments for cancer.
- Calculating radiation dose distributions from CT or other imported patient imaging.
- Developing treatment plans for delivery on compatible radiation therapy systems, including linear accelerators.
- Supporting plan review and dose optimization by radiation oncologists and medical physicists.
Practical Considerations
- This is a software system rather than an implant, catheter, or other patient-inserted device; it has no physical device size or vascular access requirements.
- Compatibility with linear accelerators, imaging systems, oncology information systems, and treatment-delivery workflows must be confirmed before clinical use.
- Treatment plans require appropriate commissioning, calibration, quality assurance, and validation by qualified medical physicists.
- The system does not independently determine whether radiation therapy is appropriate; treatment decisions remain with the radiation oncology team.
- MRI safety is not applicable to the planning software itself, although MRI images may be used in a planning workflow when the imaging equipment, registration process, and local protocols support it.
Related Literature
The linked study focused on using the Monte Carlo method for dose calculation in the Elekta Versa HD system, demonstrating its accuracy and reliability. The study utilized open-source software to perform independent patient dose calculations, highlighting an alternative for clinics without commercial Monte Carlo TPS access. While the study confirmed the method's precision, it noted limitations in resource availability for widespread adoption.
Frequently Asked Questions
What is the Monaco RTP System used for?
The Monaco RTP System is used for planning radiation therapy treatments, ensuring precise dose calculations for cancer patients.
What specialties typically use this device?
Radiation oncologists and medical physicists in oncology departments and cancer treatment centers use this device.
What are the FDA-cleared indications?
The device is indicated for planning radiation therapy in patients requiring precise dose calculations for cancer 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.