# K223427: Mimics Enlight CMF

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: May 31, 2024 after 564 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 K924630 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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 5.
- K111641: Surgicase Orthognathic Software Wizard, Materialise NV (2011) Summary page 6.
- K212570: OsteoPlan System, Osteomed, LLC (2022) Summary page 6.

## Indications for use
Materialise Mimics Enlight CMF: Mimics Enlight CMF is intended for use as a software interface and imaging segmentation system for the transfer of medical imaging information to an output file. Mimics Enlight CMF is also intended to support the diagnostic and treatment planning process of maxillofacial procedures. For this purpose, Mimics Enlight CMF provides visualization, measurement and design tools. The Mimics Enlight CMF output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The fabricated output can be used for diagnostic purposes in the field of maxillofacial applications. Mimics Enlight CMF should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K223427
Methodology: https://510kreport.com/methodology