The Healthcare AI Institute / Transparency Registry
Transparency Registry · applicant

Brainlab AG: 2 FDA AI clearances

Every 510(k) clearance held by Brainlab AG under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.

DeviceDecision dateCategory
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 2025-06-13QIH
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)2023-07-14QIH

Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Brainlab AG? The disclosure rows on your entries update free on submission of public links — start here.

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