Mim Y90 Dosimetry

FDA-Cleared Indications

• For dosimetric planning and evaluation of Y-90 radioembolization procedures.
• For calculating and displaying estimated radiation dose distributions in target and surrounding tissues based on imported imaging and treatment data.

Clinical Applications

• Treatment planning for Y-90 radioembolization of liver tumors.
• Estimating radiation dose to hepatic tumors before or during treatment planning.
• Assessing estimated dose to non-target liver and other tissues after Y-90 administration.
• Reviewing post-treatment imaging and dosimetry to support evaluation of Y-90 radioembolization.

Reported off-label uses

• Research and clinical dose-response analysis for liver-directed radiation therapy.
• Retrospective comparison of planned and delivered Y-90 dose distributions in clinical studies.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• This is software, not an implantable device or radioactive product; it requires compatible imaging, activity, and treatment data for analysis.
• Results depend on the quality, registration, and completeness of imported CT, MRI, SPECT/CT, PET/CT, or other supported datasets.
• Dosimetry estimates should be interpreted by appropriately trained clinicians and do not replace review of vascular anatomy, lung shunting, liver function, or other radioembolization safety factors.
• The software itself is not a source of ionizing radiation and does not have an MRI safety designation like an implanted device; MRI safety depends on the scanner, accessories, and any other equipment used.
• It is used as part of a broader Y-90 workflow that may include angiography, technetium-99m macroaggregated albumin mapping, selective catheterization, and post-treatment imaging.