# K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

- Pathway: 510(k) (Special)
- Applicant: Brainlab AG
- Decided: Oct 16, 2025 after 70 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: 10 generations back to K896095 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout, Brainlab AG (2024) Summary page 5.

## Indications for use
The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.

Source page: https://510kreport.com/device/K252476
Methodology: https://510kreport.com/methodology