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oncentra gyn
Nucletron
Summary: Oncentra GYN is a brachytherapy planning system used primarily for gynecological cancers. Key evidence highlights its role in improving treatment accuracy and patient safety.
FDA Clearance Information
Pathway
510K
Number
K080929 ↗
Decision Date
April 16, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Oncentra GYN was cleared by the FDA via the 510(k) pathway on April 16, 2008. It is manufactured by Nucletron and classified as a Class 2 device.
What It Is
Oncentra GYN is a brachytherapy planning system designed for precise radiation dose delivery in gynecological cancer treatment. It utilizes advanced algorithms to optimize treatment plans.
Clinical Applications
Commonly used in the treatment of cervical and endometrial cancers, Oncentra GYN aids in creating detailed treatment plans that enhance the accuracy of radiation therapy.
Evidence Summary
The literature includes five studies ranging from 2010 to 2024, encompassing various study designs such as RCTs and retrospective analyses. These studies focus on dosimetric comparisons and safety improvements.
Reported Outcomes
Published studies report that Oncentra GYN improves treatment accuracy and patient safety in brachytherapy. The system's advanced planning capabilities are noted to enhance dose distribution and treatment efficacy.
Safety Profile
Reported complications include limited options for in vivo dosimetric monitoring, although new systems are being developed to address this. Overall, the device is associated with improved safety profiles.
Evidence Limitations
Current evidence lacks large-scale, long-term studies to fully establish the efficacy and safety of Oncentra GYN. Further research is needed to explore its application in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Oncentra GYN?
Oncentra GYN is indicated for use in brachytherapy planning for gynecological cancers, particularly cervical and endometrial cancers.
What outcomes have been reported in clinical studies?
Studies report improved treatment accuracy and enhanced patient safety with the use of Oncentra GYN in brachytherapy.
What complications have been reported?
Safety data indicate limited options for in vivo dosimetric monitoring, though advancements are being made to improve this aspect.
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.