Data / Medical devices / Canada / Circle Cardiovascular Imaging Inc
Circle Cardiovascular Imaging Inc: FDA-registered device maker in Calgary Alberta, Canada, 12 510(k) clearances
Circle Cardiovascular Imaging Inc is registered with the FDA (registration 3007301305) in Calgary Alberta, Canada. It lists 4 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 27, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007301305
- Address
- Suite 1800, 707 8th Avenue SW, Calgary Alberta, Canada, T2P 1H5
- Owner or operator
- Circle Cardiovascular Imaging Inc (10026988)
- Roles
- Manufacturer
- First device listed
- November 24, 2008
- Registered through
- 2026
- Brand names listed
- CVI42, StrokeSENS ASPECTS, StrokeSENS LVO, TruPlan, cmr42, cvi42
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 27, 2025 | K251027 | cvi42 Coronary Plaque Software Application | QIH | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| July 1, 2025 | K250221 | StrokeSENS ASPECTS Software Application | POK | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| October 15, 2024 | K242781 | cvi42 Software Application | QIH | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| June 7, 2024 | K241038 | Cardiac CT Function Software Application | QIH | Substantially Equivalent | Circle Cardiovascular Imaging | accessdata.fda.gov |
| December 7, 2023 | K232661 | Myocardial Strain Software Application | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging | accessdata.fda.gov |
| January 18, 2023 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| July 28, 2022 | K213998 | cvi42 Auto Imaging Software Application | QIH | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| October 14, 2021 | K212261 | StrokeSENS LVO | QAS | Substantially Equivalent | Circle Neurovascular Imaging, Inc. | accessdata.fda.gov |
| February 19, 2021 | K202212 | TruPlan | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| August 22, 2014 | K141480 | CVI42 | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| August 23, 2011 | K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
| November 20, 2008 | K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | LLZ | Substantially Equivalent | Circle Cardiovascular Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Computer-Assisted Triage And Notification Software
Updated October 27, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.