# K190874: Materialise Mimics Enlight

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jun 5, 2019 after 62 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954678 (1996). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 6.
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 6.
- K173619: Mimics inPrint, Materialise NV (2018) Summary page 6.

## Most influential descendants
- K252195: ARTICOR planner (2026), 0 descendants of its own
- K233217: Mimics Cardiac Planner (2024), 0 descendants of its own

## Indications for use
Materialise Mimics Enlight is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also intended as a software to aid in reading and interpreting DICOM compliant images for structural heart and vascular treatment options. For this purpose, Materialise Mimics Enlight provides additional visualisation and measurement tools to enable the user to screen and plan the procedure. The Materialise Mimics Enlight output file can be used for the fabrication of physical replicas of the output file using traditional additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of cardiovascular applications. Materialise Mimics Enlight should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K190874
Methodology: https://510kreport.com/methodology