Brainomix 360 e-ASPECTS— 510(k) K243294

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K243294 for Brainomix 360 e-ASPECTS, Substantially Equivalent on 2025-02-14. Applicant: Brainomix Limited. Device class: 2.

Clearance details

Applicant: Brainomix Limited
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2024-10-18
Decision date: 2025-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

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More clearances from Brainomix Limited

K260406 — Brainomix 360 Hyperdensity2026-06-12
K251983 — Brainomix 360 Triage Stroke2025-08-26
K242411 — Brainomix 360 e-Lung2025-02-19
K242123 — Brainomix 360 e-CTA2025-01-06
K233875 — Brainomix 360 e-Lung2024-05-13

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