Brainlab AG radiology AI products

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Each entry is an FDA submission, not a distinct commercial offer. Inspect the exact record before comparing evidence, asking for a quote or planning an integration.

Which exact product, version and licensed modules are in the current offer?
Do related FDA submissions document the same scope, or different functions and versions?
Which costs, support obligations and local acceptance tests remain unresolved?

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Radiology AI pricing and total cost of ownership

Clinical guide links appear when this list contains a current reviewed example. They do not classify or endorse the other entries. All buyer guides · Compare exact records · Documented families

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

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

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

Authorized purpose: Brainlab Elements Image Fusion, Image Fusion Angio, Fibertracking, Contouring, and BOLD MRI Mapping support co-registration, white-matter visualization, structure outlining, and functional-activation visualization for cranial or extracranial surgery and preplanning of cranial or extracranial radiotherapy.

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

Authorized purpose: Brainlab Elements are software applications for processing medical-image data to support image-guided surgery and radiation-treatment planning; the exact submission includes contouring, rigid and deformable image fusion, DTI fiber tracking, task-based BOLD MRI mapping, and cerebrovascular image co-registration.

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