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mim y90 dosimetry
Mim Software
Summary: Mim Y90 Dosimetry is a software tool for dosimetry planning in Y90 radioembolization procedures. It is primarily used in hepatic cancer treatments. Key evidence highlights its role in optimizing tumor dose and assessing treatment response.
FDA Clearance Information
Pathway 510K
Number K172218 ↗
Decision Date November 21, 2017
Product Code LLZ
Device Class Class 2
Evidence 0 studies
The Mim Y90 Dosimetry was cleared via the FDA 510(k) pathway on November 21, 2017. It is manufactured by Mim Software and classified as a Class 2 device under product code LLZ.
What It Is
Mim Y90 Dosimetry is a software application designed to assist clinicians in planning and evaluating Yttrium-90 radioembolization treatments. It calculates radiation doses to tumors and surrounding tissues, aiding in treatment optimization.
Clinical Applications
This device is commonly used in the treatment of hepatic cancers, including hepatocellular carcinoma and metastatic liver tumors. It provides dosimetric calculations that inform treatment planning and post-treatment evaluation.
Evidence Summary
The available literature includes 12 studies, comprising RCTs, prospective, retrospective, and other study types, conducted between 2022 and 2025. These studies explore dosimetry, treatment response, and safety in Y90 radioembolization.
Reported Outcomes
Published studies report that Mim Y90 Dosimetry aids in predicting treatment response and survival in hepatic cancer patients. It has been shown to correlate dosimetric parameters with tumor response and overall survival, particularly in chemo-refractory metastatic breast cancer and hepatocellular carcinoma.
Safety Profile
Reported complications include treatment-related adverse events associated with non-tumoral liver dose in Y90 radioembolization. Studies highlight the importance of accurate dosimetry to minimize toxicity and improve safety profiles.
Evidence Limitations
Current evidence is limited by variability in dosimetric techniques and the need for standardized protocols. Further research is needed to refine dose thresholds and validate dosimetric models across different clinical settings.
Frequently Asked Questions
What are the clinical indications for Mim Y90 Dosimetry?
Mim Y90 Dosimetry is indicated for use in planning and evaluating Y90 radioembolization treatments for hepatic cancers, including hepatocellular carcinoma and metastatic liver tumors.
What outcomes have been reported in clinical studies?
Studies have reported improved treatment response and survival rates in patients with hepatic cancers, with dosimetric parameters correlating with clinical outcomes.
What complications have been reported?
Safety data indicate that complications can include treatment-related adverse events linked to non-tumoral liver dose, emphasizing the need for precise dosimetry.
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.