PanopticAI Technologies Limited 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
PanopticAI Vital Signs (1.6.1-22)510(k)May 21, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 21, 2026
PanopticAI Vital Signs510(k)Dec 23, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 23, 2024