Brainomix 360 Hyperdensity— 510(k) K260406

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K260406 for Brainomix 360 Hyperdensity, Substantially Equivalent on 2026-06-12. Applicant: Brainomix Limited.

Clearance details

Applicant: Brainomix Limited
Product code: Code QIH
Advisory panel: Radiology
Date received: 2026-02-09
Decision date: 2026-06-12
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.