Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Circle Cardiovascular Imaging, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
145 daysmedian FDA review time
219 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251027 | cvi42 Coronary Plaque Software Application | Circle Cardiovascular Imaging, Inc. | 2025-10-27 | 208 | 0 |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025-07-01 | 158 | 0 |
| K242781 | cvi42 Software Application | Circle Cardiovascular Imaging, Inc. | 2024-10-15 | 29 | 0 |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023-01-18 | 145 | 0 |
| K213998 | cvi42 Auto Imaging Software Application | Circle Cardiovascular Imaging, Inc. | 2022-07-28 | 219 | 0 |
| K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021-02-19 | 197 | 0 |
| K141480 | CVI42 | Circle Cardiovascular Imaging, Inc. | 2014-08-22 | 79 | 0 |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | Circle Cardiovascular Imaging, Inc. | 2011-08-23 | 99 | 0 |
| K082628 | CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23 | Circle Cardiovascular Imaging, Inc. | 2008-11-20 | 72 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda