Circle Cardiovascular Imaging, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Circle Cardiovascular Imaging, Inc.” (first 2008, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 152 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 79 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 197 |
| 2022 | 1 | 219 |
| 2023 | 2 | 122 |
| 2024 | 2 | 40 |
| 2025 | 2 | 183 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Circle Cardiovascular Imaging, Inc. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 1 | 1 |
Review panels
- Radiology (11)
Most recent Circle Cardiovascular Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251027 | cvi42 Coronary Plaque Software Application | QIH | 2025-10-27 | 208 |
| K250221 | StrokeSENS ASPECTS Software Application | POK | 2025-07-01 | 158 |
| K242781 | cvi42 Software Application | QIH | 2024-10-15 | 29 |
| K241038 | Cardiac CT Function Software Application | QIH | 2024-06-07 | 52 |
| K232661 | Myocardial Strain Software Application | LLZ | 2023-12-07 | 98 |
| K222593 | TruPlan Computed Tomography (CT) Imaging Software | LLZ | 2023-01-18 | 145 |
| K213998 | cvi42 Auto Imaging Software Application | QIH | 2022-07-28 | 219 |
| K202212 | TruPlan | LLZ | 2021-02-19 | 197 |
| K141480 | CVI42 | LLZ | 2014-08-22 | 79 |
| K111373 | CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE | LLZ | 2011-08-23 | 99 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Circle Cardiovascular Imaging, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Circle Rubber Corp. (5 510(k)s)
- Circle Hearing Instruments, Inc. (1 510(k)s)
- Circle Neurovascular Imaging, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Circle Cardiovascular Imaging, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Circle Cardiovascular Imaging, Inc.” (first 2008, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Circle Cardiovascular Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Circle Cardiovascular Imaging, Inc. is 99 days. Since 2017: 152 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Circle Cardiovascular Imaging, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); QIH (Automated Radiological Image Processing Software, 4); POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, 1).
Next steps
- See all 11 Circle Cardiovascular Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Circle Cardiovascular Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.