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

FDA 510(k) Regulatory Record - Brainomix Limited Radiology ✕

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