Circle Cardiovascular Imaging, Inc. FDA Approvals

0 new drug approvals and 6 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
cvi42 Coronary Plaque Software Application510(k)Oct 27, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2025
StrokeSENS ASPECTS Software Application510(k)Jul 1, 2025Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2025
cvi42 Software Application510(k)Oct 15, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 15, 2024
TruPlan Computed Tomography (CT) Imaging Software510(k)Jan 18, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 18, 2023
cvi42 Auto Imaging Software Application510(k)Jul 28, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 28, 2022
TruPlan510(k)Feb 19, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 19, 2021