Salix Central

K243038

Artrya Limited · cleared 2025-03-27 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Salix Central is a web-based software application that is intended to be used for viewing, post-processing, and analyzing cardiac computed tomography (CT) images acquired from a CT scanner in a Digital Imaging and Communications in Medicine (DICOM) Standard format.”

AlgorithmML-enabled algorithms

source quote (p.6)

“A reference standard was created to train the machine learning (ML) enabled algorithms in Salix Central.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.9)

“Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices".”

Validation studies (1)

Retrospective clinical

n=363 cases · 6 site(s)

endpoints: Pearson Correlation for Calcium Scoring; True Placement Percentage for Centerline Extraction; F1 Score for Vessel Labelling; Dice Score for Lumen Wall Segmentation; Dice Score for Vessel Wall Segmentation

standards: FDA 21 CFR Part 820.30, IMDRF/SaMD WG/N12FINAL:2014, ISO 13485:2016, IEC 62304:2015, ISO 14971:2019, NEMA 3.1-3.20 (2016) DICOM standards

Reported performance (3 observations)

f1as written: “F1 Score (Vessel Labelling)”78.4CI [96.1%, 80.5%]

source quote (p.10)

“78.4% [96.1%, 80.5%]”

diceas written: “Dice Score (Lumen Wall Segmentation)”0.8996CI (0.8938, 0.9055)

source quote (p.10)

“0.8996 (0.8938, 0.9055)”

diceas written: “Dice Score (Vessel Wall Segmentation)”0.9016CI (0.8962, 0.9070)

source quote (p.10)

“0.9016 (0.8962, 0.9070)”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).