đź“Š Evidence-Based Reference
clearcalc
Radformation
Summary: ClearCalc is a secondary dose calculation software by Radformation, primarily used in radiotherapy settings. Key evidence supports its validation for efficient patient-specific quality assurance.
FDA Clearance Information
Pathway
510K
Number
K193640 ↗
Decision Date
April 9, 2020
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
ClearCalc was cleared by the FDA through the 510(k) pathway on April 9, 2020. It is manufactured by Radformation and classified as a Class 2 device under product code MUJ.
What It Is
ClearCalc is a software tool designed for secondary dose calculations in radiotherapy. It is intended to verify treatment planning system calculations, ensuring accurate dose delivery in clinical settings.
Clinical Applications
ClearCalc is commonly used in radiotherapy departments for patient-specific quality assurance and verification of treatment plans. It is particularly useful in busy clinical environments where machine time for pretreatment quality assurance is limited.
Evidence Summary
The available literature includes six studies, with publication years ranging from 2024 to 2025. These studies encompass various types, including retrospective and technical reports, focusing on the validation and implementation of ClearCalc.
Reported Outcomes
Published studies report that ClearCalc is effective for secondary dose calculations and quality assurance in radiotherapy. It has been validated for use in busy clinical settings, providing reliable verification of treatment planning system calculations.
Safety Profile
Reported complications include discrepancies in dose calculations when compared to treatment planning systems, although these are within acceptable limits. No significant adverse events have been documented in the available studies.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for clearcalc?
ClearCalc is indicated for use in radiotherapy settings for secondary dose calculations and verification of treatment planning system calculations.
What outcomes have been reported in clinical studies?
Studies have reported that ClearCalc effectively validates treatment planning system calculations, ensuring accurate dose delivery in radiotherapy.
What complications have been reported?
Reported complications include minor discrepancies in dose calculations, but no significant adverse events have been documented.
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.