Omniscient Neurotechnology Pty Ltd (O8t) 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
Quicktome Software Suite510(k)May 30, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	May 30, 2023
Quicktome510(k)Mar 9, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 9, 2021