Radiology AI Directory

Vendor

Brainlab AG

3 FDA-cleared listings in this directory.

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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

RT Elements is intended to assist in stereotactic, conformal, computer-planned, and linear-accelerator-based radiation treatment planning for cranial, head-and-neck, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Cranial, head-and-neck, and extracranial lesions
Decision
2025-06-17
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

Brainlab Elements Image Fusion, Image Fusion Angio, Fibertracking, Contouring, and BOLD MRI Mapping support co-registration, white-matter visualization, structure outlining, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Cranial, cerebrovascular, and extracranial anatomy
Decision
2025-06-13
Radiotherapy planning
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

Brainlab Elements 6.0 processes medical-image data for image-guided surgery and radiation-treatment planning, including contouring, rigid or deformable image fusion, cranial...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Patient medical-image data for image-guided surgery and radiation-treatment planning, including cranial white matter, task-based BOLD MRI, and cerebrovascular data
Decision
2023-07-14
Radiological images; modality varies or is not specified in FDA list workflow