Data / Medical devices / United Kingdom / Brainomix Limited

Brainomix Limited: FDA-registered device maker in Oxford Oxfordshire, United Kingdom, 13 510(k) clearances

Name: Brainomix Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Brainomix Limited is registered with the FDA (registration 3017210169) in Oxford Oxfordshire, United Kingdom. It lists 5 device types. The FDA files 13 510(k) clearances under its listings, the newest dated June 12, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017210169
Address: First Floor, Seacourt tower West Way, Oxford Oxfordshire, United Kingdom, OX2 0JJ
Owner or operator: Brainomix Limited (10076467)
Roles: Complaint file establishment, Manufacturer
First device listed: July 20, 2020
Registered through: 2027
Brand names listed: Brainomix 360 Hyperdensity, Brainomix 360 Triage ICH, Brainomix 360 Triage LVO, Brainomix 360 Triage Stroke, Brainomix 360 e-ASPECTS, Brainomix 360 e-CTA, Brainomix 360 e-CTP, Brainomix 360 e-Lung and more

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	POK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Radiological Computer-Assisted Triage And Notification Software	QAS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 12, 2026	K260406	Brainomix 360 Hyperdensity	QIH	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
August 26, 2025	K251983	Brainomix 360 Triage Stroke	QAS	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
February 19, 2025	K242411	Brainomix 360 e-Lung	JAK	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
February 14, 2025	K243294	Brainomix 360 e-ASPECTS	POK	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
January 6, 2025	K242123	Brainomix 360 e-CTA	LLZ	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
May 13, 2024	K233875	Brainomix 360 e-Lung	JAK	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
November 21, 2023	K232496	Brainomix 360 Triage Stroke	QAS	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
September 28, 2023	K231837	Brainomix 360 Triage LVO	QAS	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
August 30, 2023	K231656	Brainomix 360 e-MRI	LLZ	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
July 27, 2023	K231195	Brainomix 360 Triage ICH	QAS	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
June 1, 2023	K223555	Brainomix 360 e-CTP	LLZ	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
February 23, 2023	K221564	Brainomix 360 e-ASPECTS	POK	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov
May 28, 2020	K192692	Brainomix 360 e-CTA	LLZ	Substantially Equivalent	Brainomix Limited	accessdata.fda.gov

Compare with other makers

Updated June 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.