Company ยท CA
Circle Cardiovascular Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 27, 2025 | K251027 | cvi42 Coronary Plaque Software Application Circle Cardiovascular Imaging, Inc., CA | QIH |
| Jul 1, 2025 | K250221 | StrokeSENS ASPECTS Software Application Circle Cardiovascular Imaging, Inc., CA | POK |
| Oct 15, 2024 | K242781 | cvi42 Software Application Circle Cardiovascular Imaging, Inc., CA | QIH |
| Jun 7, 2024 | K241038 | Cardiac CT Function Software Application Circle Cardiovascular Imaging, CA | QIH |
| Dec 7, 2023 | K232661 | Myocardial Strain Software Application Circle Cardiovascular Imaging, CA | LLZ |
| Jan 18, 2023 | K222593 | TruPlan Computed Tomography (CT) Imaging Software Circle Cardiovascular Imaging, Inc., CA | LLZ |
| Jul 28, 2022 | K213998 | cvi42 Auto Imaging Software Application Circle Cardiovascular Imaging, Inc., CA | QIH |
| Feb 19, 2021 | K202212 | TruPlan Circle Cardiovascular Imaging, Inc., CA | LLZ |
| Aug 22, 2014 | K141480 | CVI42 Circle Cardiovascular Imaging, Inc., CA | LLZ |
| Aug 23, 2011 | K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE Circle Cardiovascular Imaging, Inc., CA | LLZ |
| Nov 20, 2008 | K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 Circle Cardiovascular Imaging, Inc., CA | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||