SimBioSys, Inc. FDA Approvals

0 new drug approvals and 4 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
TumorSight Risk510(k)Sep 25, 2026Pathology	Pathology	510(k)Substantially Equivalent (Traditional)	Sep 25, 2026
TumorSight Viz510(k)Jul 8, 2025Radiology	Radiology	510(k)Substantially Equivalent (Special)	Jul 8, 2025
TumorSight Viz510(k)Oct 25, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 25, 2024
TumorSight Viz510(k)Dec 26, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 26, 2023