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dose volume histogram dvh evaluator
Diversilabs
Summary: The dose volume histogram DVH evaluator by Diversilabs is a device used to assess radiation dose distributions in clinical settings. Key evidence highlights its role in improving treatment planning precision and patient-specific quality assurance.
FDA Clearance Information
Pathway
510K
Number
K092928 ↗
Decision Date
December 16, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The dose volume histogram DVH evaluator was cleared by the FDA via the 510(k) pathway on December 16, 2009. Manufactured by Diversilabs, it is classified as a Class 2 device under product code MUJ.
What It Is
The dose volume histogram DVH evaluator is a medical device designed to analyze and evaluate radiation dose distributions in treatment planning. It is intended for use in clinical settings to optimize radiation therapy by assessing dose-volume relationships.
Clinical Applications
This device is commonly used in radiation oncology to evaluate and optimize treatment plans for various cancers, including head and neck, cervix, and other anatomical sites. It aids clinicians in ensuring accurate dose delivery to target volumes while minimizing exposure to surrounding healthy tissues.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and other study types. The studies span from 2006 to 2024, providing a comprehensive overview of the device's clinical utility.
Reported Outcomes
Published studies report that the DVH evaluator improves the precision of dose-volume histogram calculations across different treatment planning systems. It has been associated with better treatment planning consistency and enhanced patient-specific quality assurance, particularly in head and neck radiotherapy.
Safety Profile
Reported complications include potential discrepancies in dose-volume histogram calculations due to system-specific variations. However, no significant adverse events directly related to the device's use have been documented in the available studies.
Evidence Limitations
Evidence gaps include the need for more large-scale, multicenter trials to validate the device's efficacy across diverse clinical settings. Study limitations often involve small sample sizes and variability in treatment planning systems, which may affect generalizability.
Frequently Asked Questions
What are the clinical indications for dose volume histogram dvh evaluator?
The device is indicated for use in evaluating radiation dose distributions in treatment planning, particularly in radiation oncology for cancers such as head and neck and cervix.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved precision in dose-volume histogram calculations and enhanced treatment planning consistency.
What complications have been reported?
Safety data indicate potential calculation discrepancies due to system-specific variations, but no significant adverse events have been reported.
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.