Circle Cardiovascular Imaging Inc
Calgary Alberta, CA
CIRCLE CARDIOVASCULAR IMAGING INC appears in FDA device records in Calgary Alberta, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Circle Cardiovascular Imaging Inc between 2008 and 2025. The busiest year on record is 2023, with 2. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251027 | cvi42 Coronary Plaque Software Application | QIH | Substantially Equivalent | |
| K250221 | StrokeSENS ASPECTS Software Application | POK | Substantially Equivalent | |
| K242781 | cvi42 Software Application | QIH | Substantially Equivalent | |
| K241038 | Cardiac CT Function Software Application | QIH | Substantially Equivalent | |
| K232661 | Myocardial Strain Software Application | LLZ | Substantially Equivalent | |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | LLZ | Substantially Equivalent | |
| K213998 | cvi42 Auto Imaging Software Application | QIH | Substantially Equivalent | |
| K202212 | TruPlan | LLZ | Substantially Equivalent | |
| K141480 | CVI42 | LLZ | Substantially Equivalent | |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | LLZ | Substantially Equivalent | |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007301305 | 3007301305 | CIRCLE CARDIOVASCULAR IMAGING INC | Suite 1800, 707 8th Avenue SW, Calgary Alberta T2P 1H5 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain