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oncentra brachy
Nucletron
Summary: Oncentra Brachy is a brachytherapy treatment planning system by Nucletron, primarily used for high-dose-rate (HDR) brachytherapy. Key evidence highlights its application in cervical and prostate cancer treatment planning.
FDA Clearance Information
Pathway
510K
Number
K132816 ↗
Decision Date
June 13, 2014
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Oncentra Brachy received FDA clearance via the 510(k) pathway on June 13, 2014. It is manufactured by Nucletron and classified as a Class 2 medical device.
What It Is
Oncentra Brachy is a treatment planning system designed for HDR brachytherapy. It facilitates precise dose calculations and treatment planning for cancers such as cervical and prostate, using advanced algorithms and imaging techniques.
Clinical Applications
Commonly used in the treatment of cervical and prostate cancers, Oncentra Brachy aids in planning and delivering HDR brachytherapy. It is particularly useful in scenarios requiring precise dosimetry and individualized treatment plans.
Evidence Summary
The available literature includes 10 studies, comprising prospective and retrospective analyses, published between 2021 and 2025. These studies explore various aspects of HDR brachytherapy planning and implementation.
Reported Outcomes
Published studies report successful validation of HDR brachytherapy dosimetry for cervical cancer and the feasibility of MRI-guided surface brachytherapy. Additionally, the integration of AI-based treatment planning has shown promising initial clinical experiences.
Safety Profile
Reported complications include challenges in integrating new imaging modalities and algorithms into clinical practice. However, specific adverse events related to the device itself are not detailed in the provided evidence.
Evidence Limitations
The evidence base is limited by the relatively small number of studies and the early stage of AI integration in clinical practice. Further research is needed to validate long-term outcomes and safety across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Oncentra Brachy?
Oncentra Brachy is indicated for use in HDR brachytherapy, particularly for cervical and prostate cancers.
What outcomes have been reported in clinical studies?
Studies have reported successful dosimetry validation for cervical cancer and feasibility of MRI-guided brachytherapy.
What complications have been reported?
Reported complications include integration challenges with new imaging and planning technologies.
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.