Circle Cardiovascular Imaging, Inc. is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Circle Cardiovascular Imaging, Inc. - FDA 510(k) Cleared Devices
Recent clearances: cvi42 Coronary Plaque Software Application, StrokeSENS ASPECTS Software Application, cvi42 Software Application
9
Total
9
Cleared
0
Denied
Circle Cardiovascular Imaging, Inc. has 9 FDA 510(k) cleared medical devices. Based in Calgary, Alberta, CA.
Latest FDA clearance: Oct 2025. Active since 2008. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Circle Cardiovascular Imaging, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Circle Cardiovascular Imaging, Inc.
9 devices
Cleared
Oct 27, 2025
cvi42 Coronary Plaque Software Application
Radiology
208d
Cleared
Jul 01, 2025
StrokeSENS ASPECTS Software Application
Radiology
158d
Cleared
Oct 15, 2024
cvi42 Software Application
Radiology
29d
Cleared
Jan 18, 2023
TruPlan Computed Tomography (CT) Imaging Software
Radiology
145d
Cleared
Jul 28, 2022
cvi42 Auto Imaging Software Application
Radiology
219d
Cleared
Feb 19, 2021
TruPlan
Radiology
197d
Cleared
Aug 22, 2014
CVI42
Radiology
79d
Cleared
Aug 23, 2011
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
Radiology
99d
Cleared
Nov 20, 2008
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
Radiology
72d