Brainomix Limited FDA Approvals

0 new drug approvals and 12 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Brainomix 360 Hyperdensity510(k)Jun 12, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 12, 2026
Brainomix 360 Triage Stroke510(k)Aug 26, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 26, 2025
Brainomix 360 e-Lung510(k)Feb 19, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 19, 2025
Brainomix 360 e-ASPECTS510(k)Feb 14, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 14, 2025
Brainomix 360 e-CTA510(k)Jan 6, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2025
Brainomix 360 e-Lung510(k)May 13, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 13, 2024
Brainomix 360 Triage Stroke510(k)Nov 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 21, 2023
Brainomix 360 Triage LVO510(k)Sep 28, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 28, 2023
Brainomix 360 e-MRI510(k)Aug 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 30, 2023
Brainomix 360 Triage ICH510(k)Jul 27, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 27, 2023
Brainomix 360 e-CTP510(k)Jun 1, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 1, 2023
Brainomix 360 e-ASPECTS510(k)Feb 23, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 23, 2023