cvi42 Coronary Plaque Software Application

K251027

Circle Cardiovascular Imaging, Inc. · cleared 2025-10-27 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmArtificial Intelligence/Machine Learning (AI/ML) algorithm to detect lumen and vessel wall structures and post-processing methods to detect the presence and type of coronary plaque.
source quote (p.6)
“The Coronary Plaque Module implements an Artificial Intelligence/Machine Learning (AI/ML) algorithm to detect lumen and vessel wall structures. Further, the module implements post-processing methods to convert coronary artery lumen and vessel wall structures to editable surfaces and detect the presence and type of coronary plaque in the region between the lumen and vessel wall.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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 (1)

Retrospective clinical

sample size not stated

endpoints: Lumen Mean DSC; Wall Mean DSC; Lumen Mean HD; Wall Mean HD; TP PCC; CP PCC; NCP PCC; LAP PCC

standards: ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, DICOM standards

Reported performance (2 observations)

diceas written: “Lumen Mean DSC”0.76
source quote (p.13)
“Lumen Mean DSC 0.76 Pass”
diceas written: “Wall Mean DSC”0.8
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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251027