# K213684: SurgiCase Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Materialise NV
- Decided: Jun 15, 2022 after 205 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). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170419: SurgiCase Viewer, Materialise NV (2017) Summary page 5.
- K183105: Mimics Medical, Materialise NV (2019) Summary page 5.

## Most influential descendants
- K260206: SkeletonPlanner (2026), 0 descendants of its own

## Indications for use
SurgiCase Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.

Source page: https://510kreport.com/device/K213684
Methodology: https://510kreport.com/methodology