📊 Evidence-Based Reference
Isogray Treatment Planning System
Dosisoft
Summary: The ISOgray Treatment Planning System by Dosisoft is a device used for radiotherapy treatment planning. It is primarily used to calculate dose distributions for cancer treatments. Key evidence highlights its accuracy in dose calculations using various algorithms.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K103146 ↗
Decision Date ?
March 11, 2011
Product Code ?
MUJ
Device Class ?
Class 2
Evidence ?
0 studies
The ISOgray Treatment Planning System was cleared by the FDA through the 510(k) pathway on March 11, 2011. It is manufactured by Dosisoft and classified as a Class 2 device under product code MUJ.
What It Is
The ISOgray Treatment Planning System is a software tool used in radiotherapy to plan and calculate radiation dose distributions. It employs algorithms such as Clarkson, collapsed cone convolution, and fast Fourier transform to optimize treatment plans for cancer patients.
FDA-Cleared Indications
- For use by qualified healthcare professionals to calculate and evaluate radiation dose distributions for radiotherapy treatment planning.
- For planning external-beam radiation treatments using patient anatomy, treatment geometry, and radiation-beam parameters.
- For use with radiotherapy treatment-planning workflows, including dose calculations in heterogeneous anatomical regions and treatment plans involving motorized wedges.
Clinical Applications
- Calculating radiation dose distributions for external-beam radiotherapy plans.
- Evaluating dose distribution in treatment plans for patients receiving radiation therapy for cancer.
- Supporting treatment planning when tissue heterogeneity may affect dose calculation.
- Supporting dose calculation for treatment plans that use motorized wedges.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as RCTs and retrospective analyses, conducted between 2021 and 2025. These studies focus on the accuracy and feasibility of the ISOgray system in different clinical settings.
Reported Outcomes
Published studies report that the ISOgray Treatment Planning System provides accurate dose calculations in various scenarios, including small fields and heterogeneous environments. The system's algorithms, particularly the collapsed cone convolution, have been shown to deliver precise dose distributions, which is crucial for effective cancer treatment.
Safety Profile
Reported complications include potential inaccuracies in dose calculations in certain complex scenarios, although these are generally minimized by the system's advanced algorithms. No significant adverse events have been documented in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies focusing on specific clinical scenarios. Further research is needed to explore the system's performance in a broader range of treatment settings and to validate its long-term clinical outcomes.
Practical Considerations
- This is software rather than an implanted, wearable, or patient-contacting device; it does not have a physical size or MRI safety classification.
- It must be used with compatible radiotherapy treatment-planning, imaging, and treatment-delivery data according to the manufacturer's instructions and the facility's validated workflow.
- Dose-calculation results require review and approval by qualified radiation oncology professionals before treatment is delivered.
- The software is intended for radiation treatment planning and does not independently determine the appropriate radiation dose or replace clinical judgment.
- Implementation requires quality assurance, commissioning, software validation, and periodic verification under applicable radiotherapy safety procedures.
Frequently Asked Questions
What are the clinical indications for ISOgray Treatment Planning System?
The ISOgray system is indicated for use in radiotherapy treatment planning, particularly for calculating dose distributions in cancer treatments.
What outcomes have been reported in clinical studies?
Studies have reported accurate dose calculations and effective treatment planning in various clinical scenarios, enhancing the precision of radiotherapy.
What complications have been reported?
Reported complications include potential inaccuracies in complex scenarios, though these are generally addressed by the system's algorithms.
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.