Radiology AI Directory

FDA-cleared profile

cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc.

Authorized purpose: cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the presence and extent of coronary plaques and stenoses in CCTA for CAD or suspected CAD.

Cardiac imagingDetection and CADeQuantification and segmentation
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the presence and extent of coronary plaques and stenoses in CCTA for CAD or suspected CAD.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the presence and extent of coronary plaques and stenoses in CCTA for CAD or suspected CAD.

Evidence takeaway

Evidence from the reviewed source record: K251027 FDA evidence is a regulatory ML segmentation and plaque-volume validation package; no independent publication or trial was promoted in this review.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the presence and extent of coronary plaques and stenoses in CCTA for CAD or suspected CAD.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Intended users
Qualified medical professionals experienced in examining cardiovascular CT images as part of comprehensive diagnostic decision-making.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Care setting and population
Adult cardiac CT/CCTA interpretation in cardiology or radiology practice.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Workflow role
Post-processing and semi-automated plaque and stenosis assessment to provide qualitative and quantitative information for physician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Required input
Adult cardiac CT images acquired from a CT scanner in DICOM format for CCTA evaluation of CAD or suspected CAD.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Output and human action
Calcified, non-calcified, low-attenuation, and total plaque volumes and burdens; remodeling index; diameter- and area-based stenosis; lesion length; on-screen results and a Coronaries Plaque Module report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Limitations
The software is an adjunct to comprehensive physician interpretation, is limited to cardiac CT from a CT scanner, and its semi-automated algorithms are intended for adults. The public K251027 packet does not establish clinical outcomes or product-wide diagnostic accuracy beyond the reported regulatory endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K251027
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Anatomy
Heart/Cardiovascular
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-10-27
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The FDA packet describes DICOM-compliant CT import and display, cardiac CT post-processing, and reporting; compatibility with a specific PACS, RIS, EHR, interface engine, and local routing configuration requires acceptance testing.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Circle describes the current cvi42 Plaque family as on-premise and says data need not be sent to an outside reading service; the official page is not a scoped security attestation for the K251027 release.
  • Public source
  • Product family
  • Checked 2026-09-07

Confirm deployed version, network boundaries, identity, encryption, audit, retention, vulnerability management, and incident response.

Training and support
Use is limited to qualified medical professionals experienced in cardiovascular CT; local training and competency for plaque editing, report review, and failure handling remain site responsibilities.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Monitoring and change control
Monitor eligible CCTA inputs, segmentation and plaque edits, report completeness, failed or repeated analyses, PACS/RIS delivery, reader overrides, subgroup performance, downtime, updates, complaints, and recalls by exact K251027 release.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07

Buyer acceptance guidance derived from the exact FDA input, output, and validation scope.

DICOM cardiac CT workflow

The exact submission imports and displays DICOM cardiac CT and provides semi-automated plaque and vessel analysis with manual review controls.

exact submission · checked 2026-09-07
Source

On-premise family workflow

Circle describes current cvi42 Plaque as on-premise, AI-enabled plaque quantification integrated into the CT workflow without sending data to an outside reading service.

product family · checked 2026-09-07

Current family capability; verify whether the installed K251027 release, licensing, and local integration match this description.

Source

Regulatory identity cross-check

Circle's regulatory page lists cvi42 FDA 510(k) K251027; the page does not establish every current family feature for that exact cleared configuration.

exact submission · checked 2026-09-07
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K251027 FDA evidence is a regulatory ML segmentation and plaque-volume validation package; no independent publication or trial was promoted in this review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-07
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Lumen mean DSC

0.76 Dice similarity coefficient

  • EndpointMean lumen segmentation overlap against three-expert reference
  • PopulationValidation images from multiple U.S. sites and major CT vendors; public summary does not state a case count
  • Tested versioncvi42 Coronary Plaque Module in K251027
Source

Wall mean DSC

0.8 Dice similarity coefficient

  • EndpointMean vessel-wall segmentation overlap against three-expert reference
  • PopulationValidation images from multiple U.S. sites and major CT vendors
  • Tested versioncvi42 Coronary Plaque Module in K251027
Source

Low-attenuation plaque volume PCC

0.74 Pearson correlation coefficient

  • EndpointCorrelation of derived low-attenuation plaque volume with reference
  • PopulationValidation images from multiple U.S. sites and major CT vendors
  • Tested versioncvi42 Coronary Plaque Module in K251027
Source

K251027 machine-learning validation of the Coronary Plaque Module

  • DesignRetrospective regulatory validation against reference standards established by three expert annotators; development and validation images were separated.
  • PopulationAdult cardiac CT/CCTA images from multiple U.S. sources and major CT vendors
  • Scopeexact submission
  • Tested versioncvi42 Coronary Plaque Software Application configuration described in K251027
  • IndependenceSponsor or vendor study

K251027

Manufacturer-submitted FDA evidence; it is not an independent clinical-outcome study.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

No public list price or contract unit for the exact K251027 configuration was established in the reviewed official sources.

Reimbursement and coding
CMS LCD L39913 v7 and Article A59813 v6 provide conditional service-level policy context for AI-QCT/AI-CPA after completed and interpreted CCTA in WPS Medicare J5/J8 for selected symptomatic chest-pain patients; exact product/version eligibility and individual claim eligibility are not established.
  • Public source
  • Product family
  • Checked 2026-09-07

Service-level policy context; exact product/version and individual claim eligibility are not established. This is not a product code assignment, universal Medicare coverage determination, fee, or price.

75577

Conditional service-level coverage; product eligibility unconfirmed

Medicare / WPS · United States - WPS J5/J8 jurisdictions · Effective 2026-01-01

CMS policy context applies to an eligible CCTA plaque-analysis service in a limited WPS policy scope; it does not assign coverage to K251027 or establish individual claim eligibility.

SourceSource

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The wave22 exact-submission recall query returned no native recall record for K251027. This does not establish absence of family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-07

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The stored PubMed and ClinicalTrials.gov candidate arrays were screened and were empty. No paper or trial was promoted; empty stored arrays do not establish that no external literature or trials exist. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, vendor product page, vendor regulatory page, payer policy, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA 510(k) K251027: cvi42 Coronary Plaque Software Application

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: identity, clinicalUse, modality, anatomy, intendedUsers, careSetting, workflowRole, input, output, limitations, integration, evidenceMetrics, evidenceStudies

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. cvi42 Coronary Plaque Software Application model card (K251027)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. cvi42 | Plaque official product page

    Circle Cardiovascular Imaging - Accessed 2026-09-07

    Scope: productFamily, clinicalUse, implementationCapabilities, security

  8. Circle CVI U.S. regulatory clearances

    Circle Cardiovascular Imaging - Accessed 2026-09-07

    Scope: identity, productFamily, currentCommercialContext

  9. openFDA exact recall query for K251027

    U.S. Food and Drug Administration - Accessed 2026-09-07

    Scope: postmarketSafety

  10. CMS LCD L39913 version 7

    Centers for Medicare & Medicaid Services - Accessed 2026-09-07

    Scope: reimbursementPolicy

  11. CMS Article A59813 version 6

    Centers for Medicare & Medicaid Services - Accessed 2026-09-07

    Scope: reimbursementPolicy

Research history

  1. K251027 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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