Circle Cardiovascular Imaging, Inc.
FDA 510(k) & PMA Approved Devices — 6 products
Total Devices6
Categories3
Latest FDA decision2025-10-27
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251027 | cvi42 Coronary Plaque Software Application | QIH | 2025-10-27 | View |
| 510(k) | K250221 | StrokeSENS ASPECTS Software Application | POK | 2025-07-01 | View |
| 510(k) | K242781 | cvi42 Software Application | QIH | 2024-10-15 | View |
| 510(k) | K222593 | TruPlan Computed Tomography (CT) Imaging Software | LLZ | 2023-01-18 | View |
| 510(k) | K213998 | cvi42 Auto Imaging Software Application | QIH | 2022-07-28 | View |
| 510(k) | K202212 | TruPlan | LLZ | 2021-02-19 | View |
No matching devices.