Salix Coronary Plaque (V1.0.0) is a web-based adjunctive tool for qualified cardiologists and radiologists to quantify and characterize coronary plaque and stenosis and perform calcium scoring from adult cardiac CT DICOM images.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Exact purpose
Salix Coronary Plaque (V1.0.0) is a web-based adjunctive tool for qualified cardiologists and radiologists to quantify and characterize coronary plaque and stenosis and perform calcium scoring from adult cardiac CT DICOM images.
FDA source Exact FDA submission Checked 2026-09-07
The software is adjunctive and interpolated views may appear normal for lesions at or below image resolution. Automated outputs and interpolated views require qualified clinical review; the FDA evidence is regulatory technical validation rather than independent clinical-outcome evidence.
FDA source Exact FDA submission Checked 2026-09-07
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
K251837
FDA source Exact FDA submission Checked 2026-08-31
Use these fields to structure a vendor demo, security review, and implementation estimate.
Integration
The exact submission accepts cardiac CT DICOM images and operates through a secured network server with image storage; site-specific PACS/RIS routing, identifiers, and report delivery require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The FDA packet describes a web-based application with secured network-server integration and image storage; it does not establish the site hosting topology, retention, availability, or managed-service boundary for the exact release.
FDA source Exact FDA submission Checked 2026-09-07
Reviewed sources checked Exact FDA submission Checked 2026-09-07
The reviewed exact packet and Artrya family indication page do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response for K251837.
Training and support
Use requires qualified cardiologist or radiologist review of plaque, stenosis, calcium, and segmentation outputs; local onboarding should cover image eligibility, editing, interpolated-view limitations, reports, and escalation.
FDA source Exact FDA submission Checked 2026-09-07
The exact submission describes a web-based application accepting adult cardiac CT DICOM images through secured network-server integration with image storage; validate local PACS routing and identity mapping before use.
Artrya's current Salix indication describes a web-based tool for trained professionals that supports cardiac CT plaque, stenosis, and calcium scoring on CT data from any CT scanner as an adjunct to clinical judgment.
product family · checked 2026-09-07
Current family indication; confirm exact K251837 version, scanner compatibility, hosting, licensing, and local interfaces.
Buyer acceptance should test vessel labeling, centerline and wall segmentation edits, plaque composition outputs, CAD-RADS reporting, non-contrast calcium workflow, and behavior near image-resolution limits.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
K251837 FDA evidence is a seven-center regulatory validation of Salix Coronary Plaque V1.0.0 outputs; no independent paper or trial was promoted in this timeboxed review.
FDA source Exact FDA submission Checked 2026-09-07
Retrospective multi-center regulatory validation of coronary plaque, stenosis, calcium, segmentation, and labeling outputs against reference annotations. · 103 adult patients from seven geographically diverse U.S. centers; 302 non-contrast and 107 contrast series were reported across task-specific analyses.
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 K251837 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.
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 K251837 or establish individual claim eligibility.
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 K251837. This does not establish absence of family, later-version, or adverse-event information.
Public source Exact FDA submission Checked 2026-09-07
Verify security and privacy controls: The reviewed exact packet and Artrya family indication page do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response for K251837.
Verify pricing and total cost: No public list price or contract unit for the exact K251837 configuration was established in the reviewed official sources.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
12Source classes checked
0Reviewed PubMed leads
0Reviewed 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, payer policy, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
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