Circle Cardiovascular Imaging
Active in EUDAMEDCanadafrom SRN EUDAMED SRN CA-MF-000011835
Circle Cardiovascular Imaging is a medical device manufacturer based in Canada, with 10 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II) as of 14 Nov 2026.
- Devices
- 10
- Registrations
- EUDAMED
Registry facts
- Registries
- FDA GUDID 8
- EUDAMED 6
- FDA 510(k) 3
- Device classes
- EU Class IIa 5
- FDA Class II 5
- Top EMDN categories
- Sites and related companies
- Identifiers
- EUDAMED SRN CA-MF-000011835
At a glance
Market reach
- European Union
- EUDAMED actor
What Circle Cardiovascular Imaging makes
Circle Cardiovascular Imaging develops specialized software applications for MRI and CT imaging systems, focusing on cardiac and myocardial analysis. Their products include tools for cardiac CT function assessment, myocardial strain evaluation, and treatment planning, such as TruPlan. These applications are designed to enhance diagnostic capabilities for cardiovascular imaging studies.
The company’s portfolio consists of Class II medical devices, regulated under FDA pathways including 510(k) premarket notifications and the Unique Device Identifier (UDI) system. Their software applications are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device authorization requirements. The company operates from the United States.
Catalogue
- Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID
- Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Cardiac CT Function Software Application Ref K241038
Regimes: 510(k) Registry: 510(k)Myocardial Strain Software Application Ref K232661
Regimes: 510(k) Registry: 510(k)StrokeSENS Ref v2.x
Regimes: CE MDR Registry: EUDAMEDGUDIDTruPlan Ref TruPlan v2.1
Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDIDStrokeSENS Ref v1.4
Regimes: CE MDD Registry: EUDAMEDGUDIDTruPlan Ref v3.x
Regimes: CE MDR 510(k) Registry: EUDAMEDGUDIDcvi42 Ref v6.X
Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED510(k)GUDID
Company details
- EUDAMED SRN
- CA-MF-000011835
- EUDAMED status
- Active
- EUDAMED registered name
- Circle Cardiovascular Imaging Inc
- EUDAMED abbreviated name
- Circle CVI
- Registered address
- 707, 8th Avenue SW, T2P 1H5, Calgary, Canada
- PRRC contact
- Shirantha Samarappuli
Frequently asked questions
How many devices does Circle Cardiovascular Imaging have in the registry?
The registry currently lists 10 devices for Circle Cardiovascular Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Circle Cardiovascular Imaging's devices?
Among its 10 most recently registered devices, Circle Cardiovascular Imaging has devices listed in EUDAMED (6 devices), FDA 510(k) (3 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Circle Cardiovascular Imaging's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Circle Cardiovascular Imaging's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Circle Cardiovascular Imaging in the registry?
The most recently registered devices listed for Circle Cardiovascular Imaging include cvi42 5.x, cvi42 5.6, TruPlan 1.x and Cardiac CT Function Software Application.