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brachyvision 6 0
Varian Assoc.
Summary: Brachyvision 6.0 is a device used for high-dose-rate brachytherapy, primarily in cervical cancer treatment. Key evidence highlights its role in maintaining applicator stability during treatment.
FDA Clearance Information
Pathway
510K
Number
K992762 ↗
Decision Date
March 9, 2000
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
Brachyvision 6.0 was cleared through the FDA 510k pathway on March 9, 2000. Manufactured by Varian Assoc., it is classified as a Class 2 device under product code MUJ.
What It Is
Brachyvision 6.0 is a brachytherapy planning system used to deliver high-dose-rate radiation therapy. It is designed for precise dose calculation and applicator placement, particularly in intracavitary treatments for cervical cancer.
Clinical Applications
Commonly used in the treatment of cervical cancer, Brachyvision 6.0 facilitates the planning and delivery of intracavitary brachytherapy. It is also applicable in other scenarios requiring precise radiation dose delivery.
Evidence Summary
The available literature includes three studies from 2013 to 2020, covering various aspects of brachytherapy dosimetry and applicator stability. Study types include prospective and retrospective analyses.
Reported Outcomes
Published studies report that Brachyvision 6.0 effectively maintains the stability of intracavitary applicators during patient transfer, which is crucial for accurate dose delivery. The device also supports precise dosimetry in breast brachytherapy, as evidenced by mathematical modeling studies.
Safety Profile
Reported complications include potential dosimetric impacts due to applicator displacement and seroma collection in breast brachytherapy. However, specific adverse events were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for Brachyvision 6.0?
Brachyvision 6.0 is indicated for use in high-dose-rate brachytherapy, particularly for cervical cancer treatment.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of applicator stability and precise dosimetry in brachytherapy treatments.
What complications have been reported?
Reported complications include potential dosimetric impacts due to applicator displacement and seroma collection.
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.