# K212420: Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Dec 16, 2021 after 134 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: 11 generations back to K913770 (1991). 124 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183105: Mimics Medical, Materialise NV (2019) Summary page 4.
- K113732: Iplan (Iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan CMF, Iplan View, Iplan Spine), Brainlab AG (2012) Summary page 4.
- K170816: Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM, Brainlab AG (2017) Summary page 4.

## Most influential descendants
- 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) (2023), 1 descendant of its own
- K260576: MeVis AVM Contour (2026), 0 descendants of its own
- 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) (2025), 0 descendants of its own

## Indications for use
Brainlab Elements Contouring provides an interface with tools and views to outline, refine, combine and manipulate structures in patient image data. The generated 3D structures are not intended to create physical replicas used for diagnostic purposes. The device itself does not have clinical indications. Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures. The device itself does not have clinical indications. 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. The device itself does not have clinical indications. Brainlab Elements Image Fusion Angio is a software application that is intended to be used for the co-registration of cerebrovascular image data. The device itself does not have clinical indications.

Source page: https://510kreport.com/device/K212420
Methodology: https://510kreport.com/methodology