Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in CanadaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Circle Cardiovascular Imaging with 11 510(k) clearances and 9 AI-enabled devices. The most recent is a 510(k) clearance dated Oct 27, 2025: cvi42 Coronary Plaque Software Application.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 27, 2025 | cvi42 Coronary Plaque Software ApplicationK251027 · QIH | 510(k) clearances |
| Oct 27, 2025 | cvi42 Coronary Plaque Software ApplicationK251027 · Radiology | AI-enabled devices |
| Jul 1, 2025 | StrokeSENS ASPECTS Software ApplicationK250221 · POK | 510(k) clearances |
| Jul 1, 2025 | StrokeSENS ASPECTS Software ApplicationK250221 · Radiology | AI-enabled devices |
| Oct 15, 2024 | cvi42 Software ApplicationK242781 · QIH | 510(k) clearances |
| Oct 15, 2024 | cvi42 Software ApplicationK242781 · Radiology | AI-enabled devices |
| Jun 7, 2024 | Cardiac CT Function Software ApplicationK241038 · QIH | 510(k) clearances |
| Jun 7, 2024 | Cardiac CT Function Software ApplicationK241038 · Radiology | AI-enabled devices |
| Dec 7, 2023 | Myocardial Strain Software ApplicationK232661 · LLZ | 510(k) clearances |
| Dec 7, 2023 | Myocardial Strain Software ApplicationK232661 · Radiology | AI-enabled devices |
| Jan 18, 2023 | TruPlan Computed Tomography (CT) Imaging SoftwareK222593 · LLZ | 510(k) clearances |
| Jan 18, 2023 | TruPlan Computed Tomography (CT) Imaging SoftwareK222593 · Radiology | AI-enabled devices |
| Jul 28, 2022 | cvi42 Auto Imaging Software ApplicationK213998 · QIH | 510(k) clearances |
| Jul 28, 2022 | cvi42 Auto Imaging Software ApplicationK213998 · Radiology | AI-enabled devices |
| Feb 19, 2021 | TruPlanK202212 · LLZ | 510(k) clearances |
| Feb 19, 2021 | TruPlanK202212 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
