Brainlab AG radiology AI products | Vendor profile

FDA-cleared 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

Image analysis/processing for Vascular using Radiotherapy planning imaging.

Modality: Radiotherapy planning imaging
Anatomy: Vascular
Decision: 2023-07-14

Radiotherapy planning

FDA-cleared 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)

Brainlab AG

Image analysis/processing for Vascular using Radiotherapy planning imaging.

Modality: Radiotherapy planning imaging
Anatomy: Vascular
Decision: 2025-06-13

Radiotherapy planning

FDA-cleared K250440

RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT

Brainlab AG

Image analysis/processing for Neurovascular using Radiotherapy planning imaging.

Modality: Radiotherapy planning imaging
Anatomy: Neurovascular
Decision: 2025-06-17

Radiotherapy planning