Icat Solutions, Ltd. 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
Horos Mobile510(k)Apr 8, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 8, 2025
Horos MD510(k)Jan 3, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 3, 2024