Limbus Ai, Inc. FDA Approvals

0 new drug approvals and 2 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
Limbus Contour510(k)Oct 9, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 9, 2024
Limbus Contour510(k)Apr 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 7, 2023