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epigray
Dosisoft
Summary: EPIgray is an in-vivo dosimetry system by Dosisoft, primarily used for monitoring radiation dose delivery in treatments like VMAT. Key evidence highlights its effectiveness in head and neck cancer treatments.
FDA Clearance Information
Pathway
510K
Number
K112723 ↗
Decision Date
February 8, 2012
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
EPIgray was cleared by the FDA via the 510(k) pathway on February 8, 2012. It is manufactured by Dosisoft and classified as a Class 2 device.
What It Is
EPIgray is a dosimetry system that uses electronic portal imaging to calculate the dose delivered to a point of interest during radiation therapy. It is intended for use in verifying dose delivery accuracy in treatments such as VMAT.
Clinical Applications
EPIgray is commonly used in clinical scenarios involving radiation therapy, such as head and neck cancer treatments and 3D conformal radiotherapy for breast cancer. It helps ensure accurate dose delivery by comparing planned and delivered doses.
Evidence Summary
The available literature includes nine studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2021 and 2025. These studies focus on the effectiveness and optimization of EPIgray in different clinical settings.
Reported Outcomes
Published studies report that EPIgray effectively monitors dose delivery in head and neck VMAT treatments, with evidence supporting its use in optimizing 3DCRT for breast cancer. The system helps identify dose tolerance failures and improve treatment accuracy.
Safety Profile
Reported complications include potential inaccuracies due to patient positioning shifts, which can affect dose calculations. However, no significant adverse events have been documented in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies and the need for more large-scale, randomized trials. Further research is needed to explore long-term outcomes and optimize the system for various treatment modalities.
Frequently Asked Questions
What are the clinical indications for EPIgray?
EPIgray is indicated for use in verifying dose delivery accuracy in radiation therapy, particularly in VMAT and 3DCRT treatments.
What outcomes have been reported in clinical studies?
Studies have shown EPIgray to be effective in monitoring and optimizing dose delivery in head and neck and breast cancer treatments.
What complications have been reported?
Safety data indicate potential inaccuracies due to patient positioning shifts, 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.