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flexiplan brachytherapy treatment planning system
Isodose Control
Summary: Flexiplan Brachytherapy is a treatment planning system for brachytherapy, primarily used in cancer treatment. Key evidence includes dose distribution evaluations and comparisons with other planning systems.
FDA Clearance Information
Pathway
510K
Number
K081112 ↗
Decision Date
July 29, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Flexiplan Brachytherapy Treatment Planning System was cleared by the FDA via the 510(k) pathway on July 29, 2008. It is manufactured by Isodose Control and is classified as a Class 2 device.
What It Is
The Flexiplan Brachytherapy Treatment Planning System is designed to assist in the planning of brachytherapy treatments, which involve placing radioactive sources close to or within a tumor. It is used to optimize dose distribution and improve treatment accuracy.
Clinical Applications
This device is commonly used in clinical scenarios involving the treatment of cancers such as esophageal and nasopharyngeal carcinoma. It aids in precise dose calculations and treatment verification.
Evidence Summary
The available literature includes four studies, ranging from 2014 to 2020, comprising various study types such as Monte Carlo simulations and dosimetric comparisons. These studies focus on dose distribution and treatment planning accuracy.
Reported Outcomes
Published studies report that the Flexiplan system effectively evaluates dose distribution, particularly in complex anatomical regions like the nasopharynx. It has been shown to perform well in comparison with other treatment planning systems and Monte Carlo simulations.
Safety Profile
Reported complications include potential inaccuracies in dose calculations due to anatomical inhomogeneities, such as air within the trachea. No other significant adverse events were noted in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale clinical trials. Further research is needed to validate findings across diverse patient populations and clinical settings.
Frequently Asked Questions
What are the clinical indications for Flexiplan Brachytherapy?
Flexiplan is indicated for use in brachytherapy treatment planning, particularly for cancers like esophageal and nasopharyngeal carcinoma.
What outcomes have been reported in clinical studies?
Studies have reported effective dose distribution evaluations and favorable comparisons with other planning systems, particularly in complex anatomical areas.
What complications have been reported?
Safety data indicate potential inaccuracies in dose calculations due to anatomical inhomogeneities, such as air within the trachea.
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.