Medical Device Manufacturer · GB , Oxford

Brainomix Limited - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2020

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

13

Total

13

Cleared

0

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.

Brainomix Limited is one of 195 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

1-12 of 13

Cleared Jun 12, 2026

Brainomix 360 Hyperdensity

Radiology · 123d

Cleared Aug 26, 2025

Brainomix 360 Triage Stroke

Radiology · 60d

Cleared Feb 19, 2025

Brainomix 360 e-Lung

Radiology · 189d

Cleared Feb 14, 2025

Brainomix 360 e-ASPECTS

Radiology · 119d

Cleared Jan 06, 2025

Brainomix 360 e-CTA

Radiology · 171d

Cleared May 13, 2024

Brainomix 360 e-Lung

Radiology · 158d

Cleared Nov 21, 2023

Brainomix 360 Triage Stroke

Radiology · 96d

Cleared Sep 28, 2023

Brainomix 360 Triage LVO

Radiology · 98d

Cleared Aug 30, 2023

Brainomix 360 e-MRI

Radiology · 84d

Cleared Jul 27, 2023

Brainomix 360 Triage ICH

Radiology · 91d

Cleared Jun 01, 2023

Brainomix 360 e-CTP

Radiology · 185d

Cleared Feb 23, 2023

Brainomix 360 e-ASPECTS

Radiology · 268d