| K-number | K251964 |
| Device name | Mimics Thoracic Planner |
| Applicant | Materialise NV |
| Product code | LLZ |
| Device class | Class II |
| Decision date | Mar 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 892.2050 |
The Mimics Thoracic Planner is pre-procedural planning software that reviews, analyzes, and plans pulmonary or thoracic procedures using DICOM-compliant medical images. It allows clinicians to visualize, measure, annotate, and edit surgical plans before and during procedures, and perform post-operative analysis. The software must be used in conjunction with other diagnostic tools and expert clinical judgment.
The device is cloud-based software (unlike the desktop predicate Mimics Medical) using C++, Python, C#, and JavaScript/TypeScript, operating on Windows, MAC OS, and iOS. It expects pre-segmented 3D anatomical models as input rather than performing segmentation itself. It shares the same underlying Materialise technology and fundamental visualization, measurement, and planning tools as the predicate devices, with the same geometric accuracy for virtual 3D models.
Not stated in this summary.
Substantial equivalence is claimed based on identical indications for use as a pre-procedural planning software, equivalent device functionality (visualization, measurement, annotation tools), same underlying Materialise technology platform, and same design development and testing procedures as the predicate. Non-clinical performance testing verified that quantitative functions (segment volumes, lesion measurements) match the predicate device with 0.0% deviation, demonstrating equivalent safety and effectiveness.
View the full FDA submission: accessdata.fda.gov