Circle Cardiovascular Imaging
Circle Cardiovascular Imaging appears in FDA public data with 0 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 27, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251027 | cvi42 Coronary Plaque Software Application | Oct 27, 2025 |
| K250221 | StrokeSENS ASPECTS Software Application | Jul 1, 2025 |
| K242781 | cvi42 Software Application | Oct 15, 2024 |
| K241038 | Cardiac CT Function Software Application | Jun 7, 2024 |
| K232661 | Myocardial Strain Software Application | Dec 7, 2023 |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Jan 18, 2023 |
| K213998 | cvi42 Auto Imaging Software Application | Jul 28, 2022 |
| K202212 | TruPlan | Feb 19, 2021 |
| K141480 | CVI42 | Aug 22, 2014 |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | Aug 23, 2011 |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Nov 20, 2008 |