Medical Device Manufacturer · CA , Calgary, Alberta

Circle Cardiovascular Imaging, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2008

9

Total

9

Cleared

0

Denied

FDA 510(k) cleared devices by Circle Cardiovascular Imaging, Inc. Radiology ✕

9 devices

1-9 of 9

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

Radiology · 197d

Cleared Aug 22, 2014

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