# K232759: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: May 21, 2024 after 256 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191014: Elements Viewer, Brainlab AG (2020) Summary page 4.

## Most influential descendants
- K252476: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout (2025), 0 descendants of its own

## Recalls of this device
- Feb 10, 2025 · Class II · Z-1392-2025: Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification.

## 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/K232759
Methodology: https://510kreport.com/methodology