Salix Coronary Plaque (V1.0.0)
K251837Artrya Limited · cleared 2025-08-20 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Salix Coronary Plaque (V1.0.0) is a web-based, non-invasive 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.”
source quote (p.13)
“Additionally, performance validation testing was performed for the ML-enabled Salix Coronary Plaque outputs for calcium scoring, centerline extraction, vessel labelling, and lumen and vessel wall segmentation against reference ground truth established by board certified cardiologists and radiologists with SCCT Level III certification (or equivalent experience) using manual annotation and segmentation tools.”
source quote (p.13)
“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)
Reader study (MRMC)
n=103 patients · 7 site(s)
endpoints: Percentage within one CAD-RADS category; Total plaque (ICC3); Calcified plaque (ICC3); Noncalcified plaque (ICC3); Low attenuating plaque (ICC3); Calcium Scoring (Pearson Correlation); Centerline Extraction (Overlap score); Vessel Labelling (F1 Score); Lumen Wall Segmentation (Dice Score); Vessel Wall Segmentation (Dice Score)
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 (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
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
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).