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. Device class: 2.

Clearance details

Applicant: Brainomix Limited
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2025-06-27
Decision date: 2025-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QAS

K261085 — Rapid Vessel Occlusion (Rapid VO)2026-07-13
K260729 — Vascular Assist Occlusion Triage (VAOT) (v1.0)2026-06-18
K261317 — BriefCase-Triage2026-05-14
K253163 — EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)2026-04-22
K252421 — JLK-NCCT2026-03-24

More clearances from Brainomix Limited

K260406 — Brainomix 360 Hyperdensity2026-06-12
K242411 — Brainomix 360 e-Lung2025-02-19
K243294 — Brainomix 360 e-ASPECTS2025-02-14
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.