Brainomix 360 e-MRI— 510(k) K231656

Name: FDA 510(k) clearance K231656
Creator: U.S. Food and Drug Administration
Published: 2023-08-30

Substantially Equivalent

Brainomix Limited

FDA 510(k) clearance K231656 for Brainomix 360 e-MRI, Substantially Equivalent on 2023-08-30. Applicant: Brainomix Limited. Device class: 2.

Clearance details

Applicant: Brainomix Limited
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-06-07
Decision date: 2023-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Brainomix Limited

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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

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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