Brainomix 360 e-ASPECTS— 510(k) K221564

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K221564 for Brainomix 360 e-ASPECTS, Substantially Equivalent on 2023-02-23. 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: 2022-05-31
Decision date: 2023-02-23
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
K243294 — Brainomix 360 e-ASPECTS2025-02-14
K242123 — Brainomix 360 e-CTA2025-01-06

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