cvi42 Coronary Plaque Software Application
A print-ready facts sheet for procurement and governance files — public records, sources included.
Circle Cardiovascular Imaging, Inc. · cleared 2025-10-27 under product code QIH (Automated Radiological Image Processing Software).
The public record
| 510(k) number | K251027 (FDA database) |
| Device name as cleared | cvi42 Coronary Plaque Software Application |
| Applicant | Circle Cardiovascular Imaging, Inc. (Calgary, CA) |
| Decision | Substantially Equivalent · Traditional pathway |
| Decision date | 2025-10-27 |
| FDA product code | QIH — Automated Radiological Image Processing Software |
| Review panel | Radiology |
Source: openFDA 510(k) records, stored verbatim. Entry added 2026-08-29; the source link above is authoritative if any discrepancy exists.
Public disclosure beyond the clearance
| FDA clearance record | Located — linked above |
| Public model card / intended-use document | Not yet located in public sources |
| Peer-reviewed validation publication | Not yet located in public sources |
| Published subgroup / equity performance | Not yet located in public sources |
| Public monitoring or update commitments | Not yet located in public sources |
"Not yet located" is a statement about what we could find in public sources — not a statement about the product or whether such materials exist privately. Vendors: these rows update free of charge on submission of a public link — start here.
Literature mentioning this clearance number
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Method: an automated full-text search of
Europe PMC for the exact string
K251027. A result means the publication's indexed text contains this
clearance number — nothing more. It is not a finding that the publication
validates this device, and the number of results is not a score. A clearance number appears
in the literature as a predicate citation or a comparator at least as often as it appears as
the subject of a study. Re-run this search yourself.
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This entry states public facts only and is not an evaluation or recommendation of this product. Full verification path: registry record, checklist, contract terms.