đź“Š Evidence-Based Reference
3d bolus software application 3d brachy software application patient-matched 3d printed radiation therapy accessory
Adaptiiv
Summary: The 3D Bolus Software Application by Adaptiiv is a patient-matched 3D printed accessory for radiation therapy. It is primarily used to enhance dose distribution in radiotherapy. Key evidence highlights its utility in improving treatment precision.
FDA Clearance Information
Pathway
510K
Number
K213438 ↗
Decision Date
January 19, 2022
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA via the 510(k) pathway on January 19, 2022. Manufactured by Adaptiiv, it is classified as a Class 2 medical device under product code MUJ.
What It Is
The 3D Bolus Software Application is a software tool that facilitates the creation of patient-specific 3D printed boluses for radiation therapy. It is designed to improve dose conformity and accuracy in radiotherapy treatments.
Clinical Applications
Commonly used in scenarios requiring precise dose delivery, such as head and neck radiotherapy, the device aids in adapting to patient-specific anatomical changes, like weight loss, ensuring consistent treatment efficacy.
Evidence Summary
The literature includes 11 studies, encompassing randomized controlled trials, prospective, and retrospective studies, published between 2023 and 2025. These studies explore various clinical applications and outcomes of the device.
Reported Outcomes
Published studies report that the 3D Bolus Software Application enhances dose distribution accuracy in radiotherapy, particularly for complex anatomical regions. It has shown potential in improving treatment outcomes by reducing dose discrepancies due to anatomical changes.
Safety Profile
Reported complications include potential inaccuracies in body contour adaptation, which may affect dose calculations. However, no significant adverse events have been directly linked to the device's use.
Evidence Limitations
Current evidence is limited by the small sample sizes and the need for more diverse patient populations. Further research is required to validate long-term outcomes and safety across different clinical settings.
Frequently Asked Questions
What are the clinical indications for 3D Bolus Software Application?
The device is indicated for use in radiation therapy to improve dose distribution accuracy, particularly in head and neck radiotherapy.
What outcomes have been reported in clinical studies?
Studies have reported improved dose conformity and treatment precision, especially in complex anatomical regions.
What complications have been reported?
Safety data indicate potential inaccuracies in body contour adaptation, 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.