Intended Use

MIM software is intended for trained medical professionals to assist in diagnosis, staging, treatment planning, monitoring treatment response, and treatment evaluation. It provides tools for the management, visualization, quantification, and processing of digital medical images from various modalities including PET, CT, MR, and others.

Technology

MIM – KineticID is a software-based application that extends the MIM platform, offering advanced image registration, fusion, ROI-based segmentation, automated and manual contouring, automated PET/SPECT analysis using pharmacokinetic models (including Patlak analysis), and supports multiple imaging modalities via DICOM. It operates on Windows, Mac, and Linux systems and integrates features such as flexible workstation setup and user-defined workflows.

Performance

Comprehensive verification and validation testing were completed, including functional requirements, user interface, user interaction, and error handling, all within simulated real-use environments. Validation included comparisons of algorithm output (parametric maps, input function, MRFDG conversion, and Patlak models) using both simulated and real patient data, confirming all tests were successful and met predefined criteria.

Predicate Devices

No predicate devices specified

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