PathAI, 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
AISight Dx510(k)Jun 26, 2025Pathology	Pathology	510(k)Substantially Equivalent (Traditional)	Jun 26, 2025
Novo510(k)Aug 11, 2022Pathology	Pathology	510(k)Substantially Equivalent (Traditional)	Aug 11, 2022