# K052424: Maxilim

- Pathway: 510(k) (Traditional)
- Applicant: Medicim NV
- Decided: Mar 31, 2006 after 210 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.
17 later devices descend from it; 3 cite it directly.
0 of 22 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
- K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine) (2012), 8 descendants of its own
- K170816: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM (2017), 5 descendants of its own
- K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio (2021), 3 descendants of its own
- K161634: IPS CaseDesigner (2016), 3 descendants of its own
- K123976: Nobelclinician (2013), 3 descendants of its own

## Indications for use
Maxilim is indicated 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. It is also indicated for use as a planning and simulation software for surgical treatment, specifically maxillofacial treatment.

Source page: https://510kreport.com/device/K052424
Methodology: https://510kreport.com/methodology