Brainomix 360 Triage Stroke— 510(k) K251983

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K251983 for Brainomix 360 Triage Stroke, Substantially Equivalent on 2025-08-26. Applicant: Brainomix Limited.

Clearance details

Applicant: Brainomix Limited
Product code: Code QAS
Advisory panel: Radiology
Date received: 2025-06-27
Decision date: 2025-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

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Data sourced from openFDA. This site is unofficial and independent of the FDA.