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radcalc software version 6 0
Lifeline Software
Summary: RadCalc Software Version 6.0 is a medical device used for independent dose calculation in radiation therapy. It is primarily utilized by radiation oncologists and medical physicists to ensure accurate treatment delivery.
FDA Clearance Information
Pathway
510K
Number
K090531 ↗
Decision Date
May 27, 2009
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
RadCalc Software Version 6.0 was cleared through the FDA 510(k) pathway on May 27, 2009. It is manufactured by Lifeline Software and is classified as a Class II device under product code MUJ.
What It Is
RadCalc Software Version 6.0 is a software tool designed for independent verification of dose calculations in radiation therapy. It serves as a quality assurance measure, providing an additional check on the dose calculations performed by primary treatment planning systems. This ensures that the prescribed dose is accurately delivered to the patient, which is critical in treatments like brachytherapy and external beam radiation therapy.
Clinical Applications
RadCalc is commonly used in radiation oncology departments to verify treatment plans for both brachytherapy and external beam radiation therapy. It is particularly valuable in settings where precise dose delivery is crucial, such as in the treatment of cancer patients. The software is used by medical physicists to cross-verify the treatment plans generated by other systems, ensuring patient safety and treatment efficacy.
Indications for Use
The FDA-cleared indications for RadCalc Software include its use as an independent dose calculation tool in radiation therapy. It is intended for use in verifying the accuracy of treatment plans to ensure that patients receive the correct dose of radiation.
Practical Considerations
RadCalc Software is compatible with various treatment planning systems and is designed to integrate smoothly into existing workflows. It is important for users to ensure that the software is regularly updated and calibrated to maintain accuracy. Training in its use is recommended for all operators.
Related Literature
The linked study focused on the commissioning of a 3D high dose rate brachytherapy treatment planning system. It highlighted the importance of validating treatment optimization and dose volume histogram analysis. RadCalc Software Version 6.0 was used to independently verify point doses, demonstrating its utility in ensuring accurate dose delivery. The study underscored the need for rigorous testing and validation of treatment planning systems, though it did not explore long-term clinical outcomes.
Frequently Asked Questions
What is RadCalc Software used for?
RadCalc Software is used for independent verification of dose calculations in radiation therapy to ensure accurate treatment delivery.
What specialties typically use this device?
RadCalc Software is typically used by radiation oncologists and medical physicists in the field of radiation oncology.
What are the FDA-cleared indications?
RadCalc Software is indicated for use as an independent dose calculation tool to verify the accuracy of radiation therapy treatment plans.
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.