Transparency Registry · applicant

Brainomix Limited: 5 FDA AI clearances

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

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Device	Decision date	Category
Brainomix 360 Hyperdensity	2026-06-12	QIH
Brainomix 360 Triage Stroke	2025-08-26	QAS
Brainomix 360 Triage Stroke	2023-11-21	QAS
Brainomix 360 Triage LVO	2023-09-28	QAS
Brainomix 360 Triage ICH	2023-07-27	QAS

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<a href="https://healthcareaiops.com/registry/company/brainomix-limited/">Brainomix Limited — FDA AI clearances, verified in the Healthcare AI Transparency Registry</a>

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