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oncentra oncentra external beam oncentra brachy
Elekta Inc. D/B/A Nucletron
Summary: Oncentra External Beam and Brachy are radiotherapy devices by Elekta Inc. used for precise cancer treatment. Key evidence highlights their efficacy in dose calculation and treatment planning.
FDA Clearance Information
Pathway
510K
Number
K121448 ↗
Decision Date
July 2, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Oncentra devices were cleared by the FDA via the 510(k) pathway on July 2, 2012. Manufactured by Elekta Inc., they are classified as Class 2 medical devices.
What It Is
Oncentra External Beam and Brachy are advanced radiotherapy systems designed for precise delivery of radiation to cancerous tissues. They utilize sophisticated treatment planning to optimize therapeutic outcomes.
Clinical Applications
These devices are commonly used in the treatment of various cancers, including pleural and chest wall tumors, where precise radiation delivery is critical. They are also employed in scenarios requiring high-dose-rate brachytherapy.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series, spanning from 2019 to 2025.
Reported Outcomes
Published studies report that Oncentra devices provide accurate dose calculations and effective treatment planning, particularly in complex cases involving pacemakers and high-dose-rate brachytherapy for tumors. The devices are noted for their precision in radiation delivery.
Safety Profile
Reported complications include potential risks associated with radiation exposure, such as increased risk of second malignancies, particularly in pediatric patients. However, the devices are generally considered safe when used as intended.
Evidence Limitations
The evidence base is limited by the relatively small number of studies and the need for more long-term data on safety and efficacy. Further research is needed to explore outcomes in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Oncentra devices?
Oncentra devices are indicated for use in radiotherapy for cancer treatment, particularly in cases requiring precise radiation delivery, such as pleural and chest wall tumors.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective dose calculation and treatment planning, with successful outcomes in high-dose-rate brachytherapy and external beam radiotherapy.
What complications have been reported?
Safety data indicate potential complications such as increased risk of second malignancies, especially in pediatric patients, due to radiation exposure.
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.