cvi42 Coronary Plaque Software Application
K251027Circle Cardiovascular Imaging, Inc. · cleared 2025-10-27 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“Circle's cvi42 Coronary Plaque Software Application ('cvi42 Coronary Plaque' or 'Coronary Plaque Module', for short) is a Software as a Medical Device (SaMD) that enables the analysis of CT Angiography scans of the coronary arteries of the heart.”
source quote (p.6)
“The Coronary Plaque Module implements an Artificial Intelligence/Machine Learning (AI/ML) algorithm to detect lumen and vessel wall structures.”
source quote (p.12)
“The Coronary Plaque Module has been designed to meet cybersecurity requirements in accordance with FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", through the use of threat modeling, software composition analysis (SCA), static analysis, vulnerability testing, and a risk assessment based on exploitability and severity of harm.”
Validation studies (2)
Bench
sample size not stated
standards: ISO 13485:2016, IEC 62304:2019, ISO 14971:2019, DICOM
Retrospective clinical
sample size not stated
endpoints: Dice Similarity Coefficient (DSC); Hausdorff Distance (HD); Pearson Correlation Coefficient (PCC)
Reported performance (2 observations)
source quote (p.13)
“Lumen Mean DSC 0.76 Pass”
source quote (p.13)
“Wall Mean DSC 0.80 Pass”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).