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3d bolus software
3D Bolus
Summary: 3D Bolus Software is a clinician-facing tool designed to create custom boluses for radiation therapy. It is primarily used to optimize dose delivery to superficial tumors. Key evidence highlights its ability to improve conformity and reduce radiation exposure to adjacent organs.
FDA Clearance Information
Pathway
510K
Number
K180289 ↗
Decision Date
July 10, 2018
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The 3D Bolus Software was cleared by the FDA via the 510(k) pathway on July 10, 2018. It is manufactured by 3D Bolus and classified as a Class 2 device under product code MUJ.
What It Is
The 3D Bolus Software is a medical device software that facilitates the design and fabrication of custom boluses for radiation therapy. It uses advanced imaging techniques to create patient-specific boluses that enhance dose delivery to targeted areas.
Clinical Applications
This device is commonly used in radiation oncology to improve dose conformity for superficial tumors, particularly in complex anatomical regions. It is also employed to reduce radiation exposure to organs-at-risk during treatment.
Evidence Summary
The literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, published between 2023 and 2025. These studies explore the efficacy and safety of 3D-printed boluses in clinical settings.
Reported Outcomes
Published studies report that the use of 3D Bolus Software enhances dose conformity and reduces radiation exposure to adjacent organs. It has shown superior performance compared to traditional bolus methods, particularly in anatomically complex regions.
Safety Profile
Reported complications include minimal adverse events related to the use of 3D-printed boluses. The studies did not highlight significant safety concerns, indicating a favorable safety profile for the device.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for longer-term follow-up studies. Further research is needed to explore the full potential and limitations of 3D bolus technology in diverse clinical scenarios.
Frequently Asked Questions
What are the clinical indications for 3D Bolus Software?
The device is indicated for use in radiation therapy to create custom boluses for optimizing dose delivery to superficial tumors.
What outcomes have been reported in clinical studies?
Studies report improved dose conformity and reduced radiation exposure to adjacent organs compared to traditional methods.
What complications have been reported?
Safety data indicates minimal adverse events, with no significant complications reported in the studies.
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.