Terarecon,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
TeraRecon Cardiovascular.Calcification.CT510(k)Oct 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2025
TeraRecon Aorta.CT (1.1.0)510(k)Jan 23, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 23, 2025
TeraRecon Cardiac.Chambers.MR (1.0.0)510(k)Nov 5, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 5, 2024
TeraRecon Neuro510(k)Aug 12, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Aug 12, 2022