cvi42 Coronary Plaque Software Application

K251027

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

FDA 510(k) summary for cvi42 Coronary Plaque Software Application (K251027)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
2
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • predicate_cohort_contagion

    K251027 shares predicate K190868 with K202280 (Cleerly Labs v2.0), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K190868 sibling:K202280

  • predicate_cohort_contagion

    K251027 shares predicate K213998 with K242062 (1CMR Pro), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K213998 sibling:K242062

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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