| K-number | K251883 |
| Device name | MIM LesionID Pro |
| Applicant | Mim Software, Inc. |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Dec 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
MIM – LesionID Pro is a software application that assists trained medical professionals in evaluating PSMA PET/CT and SPECT/CT studies by automating hotspot segmentation and physiological uptake removal to streamline Total Tumor Burden (TTB) statistics generation. The software requires users to review, edit, and confirm segmentations before final analysis and operates on multiple platforms including Windows, macOS, and Linux-based systems supporting various DICOM medical imaging modalities.
Key differences from the predicate include automated physiological uptake identification and removal (versus manual in predicate), automated reference region generation in liver and mediastinum bloodpool ROIs (versus manual only in predicate), and automated TTB ROI generation and quantification (versus manual only in predicate). The subject device integrates with MIM Workflows and MIM Assistant for workflow automation using modular functions, and includes Contour ProtégéAI+ for automatic contouring of normal structures.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov