# K243633: Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Jun 13, 2025 after 200 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 13 generations back to K913770 (1991). 126 ancestors in all.
No later device cites it as a predicate yet.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223106: Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion  (4.5);Fibertracking (2.0);BOLD MRI Mapping  (1.0);Image Fusion Angio  (1.0), Brainlab AG (2023) Summary page 5.

## Indications for use
Brainlab Elements Image Fusion is an application for the co-registration of image data within medical procedures by using rigid and deformable registration methods. It is intended to align anatomical structures between data sets. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. It is not intended for diagnostic purposes. Brainlab Elements Image Fusion Angio is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Weighted Imaging (DWI) data for use in treatment planning procedures. It is not intended for diagnostic purposes. Brainlab Elements Fibertracking is indicated for planning of cranial surgical treatments and preplanning of cranial radiotherapy treatments. Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. It is not intended for diagnostic purposes. Brainlab Elements Contouring is indicated for planning of cranial and extracranial surgical treatments and preplanning of cranial and extracranial radiotherapy treatments. Brainlab Elements BOLD MRI Mapping provides tools to analyze blood oxygen level dependent data (BOLD MRI Data) to visualize the activation signal. It is not intended for diagnostic purposes. Brainlab Elements BOLD MRI Mapping is indicated for planning of cranial surgical treatments.

Source page: https://510kreport.com/device/K243633
Methodology: https://510kreport.com/methodology