# K073468: Mimics

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Apr 2, 2008 after 114 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: 3 generations back to K924630 (1993). 4 ancestors in all.
141 later devices descend from it; 9 cite it directly.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033849: Simplant System, Materialise NV (2004) Summary page 1.

## Most influential descendants
- K093269: Procedure Rehearsal Studio (2010), 41 descendants of its own
- K112387: Procedure Rehearsal Studio (TM) (2011), 40 descendants of its own
- K123023: Surgery Rehearsal Platform (2013), 37 descendants of its own
- K183105: Mimics Medical (2019), 34 descendants of its own
- K120956: VSP System (2012), 28 descendants of its own

## Indications for use
Mimics is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner to an output file. It is also used as pre-operative software for simulating /evaluating surgical treatment options. Mimics is not intended to be used for mammography imaging.

Source page: https://510kreport.com/device/K073468
Methodology: https://510kreport.com/methodology