đź“Š Evidence-Based Reference
peregrine radiation therapy dose calculation system
Nomos
Summary: The Peregrine Radiation Therapy Dose Calculation System by Nomos is a Monte Carlo-based treatment planning tool for radiation therapy. It is primarily used for accurate dose calculations in complex clinical scenarios. Key evidence highlights its dosimetric accuracy in intensity-modulated radiation therapy (IMRT).
FDA Clearance Information
Pathway
510K
Number
K993675 ↗
Decision Date
September 5, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Peregrine system was cleared by the FDA via the 510(k) pathway on September 5, 2000. It is manufactured by Nomos and classified as a Class 2 medical device under product code MUJ.
What It Is
The Peregrine Radiation Therapy Dose Calculation System is a Monte Carlo simulation-based software designed for precise dose calculations in radiation therapy. It is intended for use in treatment planning to ensure accurate dose delivery, particularly in complex anatomical regions.
Clinical Applications
The Peregrine system is commonly used in clinical scenarios requiring high precision in dose calculation, such as intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT). It is particularly useful in cases involving inhomogeneous tissue densities, like those found in thoracic regions.
Evidence Summary
The available literature includes 11 studies, primarily focusing on dosimetric evaluations and clinical implementations of the Peregrine system. These studies range from 2005 to 2018 and include various study types such as retrospective analyses and dosimetric evaluations.
Reported Outcomes
Published studies report that the Peregrine system provides accurate dose calculations in both homogeneous and heterogeneous phantoms. It has been shown to improve the precision of dose delivery in IMRT and SBRT, enhancing treatment efficacy by ensuring the intended dose is accurately delivered to the target tissues.
Safety Profile
Reported complications include potential inaccuracies in dose calculations if the system is not properly calibrated or if incorrect input parameters are used. However, no significant adverse events directly related to the use of the Peregrine system have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of prospective clinical trials and the reliance on dosimetric evaluations rather than clinical outcomes. Further research is needed to assess long-term clinical benefits and potential improvements in patient outcomes.
Frequently Asked Questions
What are the clinical indications for Peregrine Radiation Therapy Dose Calculation System?
The Peregrine system is indicated for use in radiation therapy treatment planning, particularly in scenarios requiring high precision dose calculations such as IMRT and SBRT.
What outcomes have been reported in clinical studies?
Studies have reported that the Peregrine system provides accurate dose calculations, improving the precision of dose delivery in complex treatment scenarios.
What complications have been reported?
Reported complications include potential inaccuracies in dose calculations due to calibration errors or incorrect input parameters, though no significant adverse events have been documented.
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.