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. Device class: 2.

Clearance details

Applicant: Brainomix Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-02-09
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Brainomix Limited

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
K233875 — Brainomix 360 e-Lung2024-05-13

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