# K173619: Mimics inPrint

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Mar 21, 2018 after 119 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: 4 generations back to K924630 (1993). 5 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073468: Mimics, Materialise NV (2008) Summary page 4.

## Most influential descendants
- K221511: Axial3D Cloud Segmentation Service (2022), 4 descendants of its own
- K222745: Axial3D Insight (2023), 2 descendants of its own
- K191026: Medip Pro (2019), 2 descendants of its own
- K190874: Materialise Mimics Enlight (2019), 2 descendants of its own
- K232841: Axial3D Insight (2023), 1 descendant of its own

## Indications for use
Mimics inPrint 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 used as pre-operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement.

Source page: https://510kreport.com/device/K173619
Methodology: https://510kreport.com/methodology