Circle Cardiovascular Imaging 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
Cardiac CT Function Software Application510(k)Jun 7, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jun 7, 2024
Myocardial Strain Software Application510(k)Dec 7, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Dec 7, 2023