Medical Device Manufacturer · GB , Oxford

Brainomix Limited - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2020

Recent clearances: Brainomix 360 Hyperdensity, Brainomix 360 Triage Stroke, Brainomix 360 e-Lung

Total

Cleared

Denied

Brainomix Limited has 13 FDA 510(k) cleared radiology devices. Based in Oxford, GB.

Latest FDA clearance: Jun 2026. Active since 2020.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Brainomix Limited is one of 428 FDA 510(k) medical device manufacturers from United Kingdom in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Brainomix Limited

13 devices

1-13 of 13

Cleared Jun 12, 2026

Brainomix 360 Hyperdensity

K260406 · QIH

Radiology · 123d

Cleared Aug 26, 2025

Brainomix 360 Triage Stroke

Brainomix 360 e-ASPECTS

Brainomix 360 Triage Stroke

K232496 · QAS

Radiology · 96d

Cleared Sep 28, 2023

Brainomix 360 Triage LVO

Brainomix 360 Triage ICH

Brainomix 360 e-ASPECTS

Brainomix Limited - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Brainomix Limited

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