📊 Evidence-Based Reference
Monaco
Impac Medical Systems
Summary: Monaco is a treatment planning system used in radiotherapy. It is primarily used for creating high-quality radiotherapy treatment plans. Key evidence highlights its accuracy in dose calculation and optimization processes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151233 ↗
Decision Date ?
July 7, 2015
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
Monaco was cleared by the FDA through the 510(k) pathway on July 7, 2015. It is manufactured by Impac Medical Systems and is classified as a Class 2 device.
What It Is
Monaco is a treatment planning system that utilizes Monte Carlo dose calculation for radiotherapy. It is designed to optimize treatment plans for various radiotherapy techniques, including 3D CRT, IMRT, VMAT, SRS, and SBRT.
FDA-Cleared Indications
- Used to calculate radiation dose and generate treatment plans for external-beam radiotherapy.
- Supports treatment planning and optimization for three-dimensional conformal radiotherapy, intensity-modulated radiotherapy, volumetric-modulated arc therapy, stereotactic radiosurgery, and stereotactic body radiotherapy.
Clinical Applications
- Planning three-dimensional conformal radiotherapy treatments
- Planning intensity-modulated radiotherapy treatments
- Planning volumetric-modulated arc therapy treatments
- Planning stereotactic radiosurgery treatments
- Planning stereotactic body radiotherapy treatments
- Calculating and optimizing radiation dose distributions for cancer treatment plans
Evidence Summary
The available literature includes 15 studies, primarily focusing on the optimization and accuracy of the Monaco treatment planning system. The studies range from 2018 to 2025, highlighting advancements in technology and application.
Reported Outcomes
Published studies report that Monaco provides high accuracy in dose distribution and optimization for radiotherapy treatments. The system's Monte Carlo algorithm is noted for its precision in aligning planned doses with actual irradiated doses.
Safety Profile
Reported complications include potential inaccuracies in dose calculation if transmission probability filters are not optimized. However, no significant adverse events have been documented in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale clinical trials directly assessing patient outcomes. Further research is needed to evaluate long-term safety and efficacy in diverse patient populations.
Practical Considerations
- Monaco is treatment-planning software, not an implanted or disposable device; it does not have physical device sizes or vascular compatibility requirements.
- Treatment plans require accurate patient imaging, treatment-machine data, structure delineation, dose constraints, and quality assurance before clinical use.
- The system is used with radiotherapy imaging and delivery equipment that has been appropriately commissioned and validated by the radiation oncology department.
- It is not an MRI-compatible device in the usual implant-safety sense; MRI images may be used for planning when the imaging workflow, registration, and geometric accuracy have been validated.
- The software does not itself deliver radiation, and clinical use remains subject to physician review, physics verification, and institutional procedures.
Frequently Asked Questions
What are the clinical indications for Monaco?
Monaco is indicated for use in planning radiotherapy treatments, including 3D CRT, IMRT, VMAT, SRS, and SBRT.
What outcomes have been reported in clinical studies?
Studies report high accuracy in dose calculation and optimization, enhancing treatment precision.
What complications have been reported?
Safety data indicate potential inaccuracies in dose calculation if system parameters are not optimized, but no significant adverse events have been reported.
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.