📊 Evidence-Based Reference
Radcalc Software
Lifeline Software
Summary: RadCalc is a software tool for dose calculation in radiation therapy. It is primarily used for quality assurance in treatment planning. Key evidence highlights its accuracy in dose calculations.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193381 ↗
Decision Date ?
December 31, 2019
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
RadCalc software was cleared by the FDA through the 510(k) pathway on December 31, 2019. It is manufactured by Lifeline Software and classified as a Class 2 device.
What It Is
RadCalc is a dose calculation software designed to verify radiation therapy treatment plans. It is used to ensure accurate dose delivery in clinical settings, particularly for complex treatment modalities.
FDA-Cleared Indications
- Used for independent verification of radiation therapy treatment-plan dose calculations.
- Used to support quality assurance for radiation therapy treatment plans.
Clinical Applications
- Patient-specific dose verification in radiation oncology.
- Independent review of calculated radiation doses before treatment delivery.
- Quality assurance for complex radiation therapy treatment plans.
- Dose verification for advanced techniques such as stereotactic body radiation therapy when included in the department's validated workflow.
Evidence Summary
The available literature includes four studies, with publication years ranging from 2017 to 2025. The studies encompass various methodologies, including experimental validation and algorithm evaluation.
Reported Outcomes
Published studies report that RadCalc provides accurate dose calculations, particularly in scenarios involving complex geometries and treatment modalities. The software's head scatter correction factors and collapsed cone dose calculation algorithm have been validated against measured data, demonstrating reliability in clinical settings.
Safety Profile
Reported complications include no specific adverse events directly associated with the use of RadCalc software. The studies primarily focus on the accuracy and reliability of dose calculations rather than safety concerns.
Evidence Limitations
The evidence is limited by the small number of studies and the focus on specific technical aspects of the software. Further research is needed to explore its application across a broader range of clinical scenarios and patient populations.
Practical Considerations
- RadCalc is software rather than an implanted or disposable device, so it does not have a physical size, vessel compatibility, or MRI safety rating.
- It must be configured and validated for the treatment-planning system, linear accelerator, radiation modality, and calculation methods used by the clinical department.
- Results are intended to support, not replace, review by qualified radiation oncology professionals and the department's quality-assurance program.
- Accurate use depends on correct treatment-plan data transfer, dose-calculation settings, commissioning, maintenance, and software-version control.
- The FDA record identifies the device as a Class II software device cleared through the 510(k) pathway; the available record does not provide a specific clinical contraindication list.
Frequently Asked Questions
What are the clinical indications for RadCalc software?
RadCalc is indicated for use in radiation therapy treatment planning and quality assurance, particularly for verifying dose calculations in complex treatment scenarios.
What outcomes have been reported in clinical studies?
Studies report that RadCalc accurately calculates radiation doses, with validated algorithms for head scatter correction and dose distribution.
What complications have been reported?
No specific complications have been reported in the evidence provided. The focus has been on the accuracy and reliability of the software's calculations.
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.