Rebrain, Sas 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
OptimMRI (v2)510(k)Aug 12, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Aug 12, 2024
OptimMRI510(k)Jul 21, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023