Salix Central is a web-based adjunctive tool for qualified professionals to view, post-process, and analyze cardiac CT DICOM images for physician-identified coronary plaque and stenosis assessment and non-contrast calcium scoring.
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 Central is a web-based adjunctive tool for qualified professionals to view, post-process, and analyze cardiac CT DICOM images for physician-identified coronary plaque and stenosis assessment and non-contrast calcium scoring.
FDA source Exact FDA submission Checked 2026-09-07
Calcium scoring; coronary centerline extraction; vessel labeling; lumen and vessel-wall segmentation; coronary measurements; and a standard coronary report for clinician review.
FDA source Exact FDA submission Checked 2026-09-07
The software is adjunctive, requires qualified professional review, and does not replace clinical judgment. FDA validation was task-specific and regulatory; it does not establish independent clinical outcomes or performance for every scanner, protocol, or later family version.
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
K243038
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 through a secured network server and stores images; local PACS/RIS routing, identifiers, report delivery, and retention require acceptance testing.
FDA source Exact FDA submission Checked 2026-09-07
The FDA packet describes a web-based application using AWS cloud services and a secured network server; it does not establish current hosting region, retention, availability, service-level terms, or the exact deployed cloud configuration.
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 pages do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response for K243038.
Training and support
Use requires qualified professional review of coronary measurements, segmentation, calcium scores, and reports; local onboarding should cover CCTA versus non-contrast inputs, editing, report review, and escalation.
FDA source Exact FDA submission Checked 2026-09-07
The exact FDA submission describes a web-based application using AWS cloud services, secured network-server connectivity, and image storage; confirm the current hosting region, data boundary, retention, and service terms with the vendor.
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 K243038 version, scanner compatibility, hosting, licensing, and local interfaces.
Artrya's investor-relations page identifies Salix Central as the U.S. product cleared under K243038; it does not establish every current family feature or contract term for the cleared configuration.
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Evidence summary
K243038 FDA evidence is a six-center regulatory validation of Salix Central cardiac CT post-processing; 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 calcium scoring, coronary centerline and labeling, and lumen/vessel-wall segmentation against reference results. · 363 unique de-identified cardiac CT studies from six centers across three U.S. states; task-specific sets included 302 non-contrast and 116 contrast studies.
exact submission · Tested version: Salix Central configuration described in K243038 · n=363 · 6 sites · Sponsor or vendor study
K243038
Manufacturer-submitted FDA evidence; it is not an independent clinical-outcome study. The FDA summary's printed confidence interval for vessel-label F1 is internally malformed and was not promoted as a metric.
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 K243038 configuration was established in the reviewed official sources.
Reimbursement and coding
Research pending
Needs research Exact FDA submission Checked 2026-09-07
CMS plaque-policy context was not applied to this dossier; no product-specific coverage determination is made.
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 K243038. 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 pages do not establish current scoped security controls, certification scope, PHI flow, retention, access control, audit, or incident response for K243038.
Verify pricing and total cost: No public list price or contract unit for the exact K243038 configuration was established in the reviewed official sources.
Verify reimbursement and coding relevance: CMS plaque-policy context was not applied to this dossier; no product-specific coverage determination is made.
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, vendor regulatory page, fda device recall, literature index, trial registry, stored candidate metadata, pubmed, clinical trials, openfda device recall
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