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.
| 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 |
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 Brainomix Limited? The disclosure rows on your entries update free on submission of public links — start here.
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