Salix Coronary Plaque (V1.0.0)

K251837

Artrya Limited · cleared 2025-08-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
AlgorithmML-enabled
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.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
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 (2)

Reader study (MRMC)

n=103 patients · 7 site(s)

endpoints: plaque volumes; CAD-RADS stenosis grades

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

Retrospective clinical

n=302 scans · 7 site(s)

endpoints: calcium scoring; centerline extraction; vessel labelling; lumen and 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)”0.8264CI 0.8047, 0.8479
source quote (p.14)
“F1 Score 0.8264 [0.8047, 0.8479]”
diceas written: “Dice Score (Lumen Wall Segmentation)”0.8996CI 0.8938, 0.9055
source quote (p.14)
“Dice Score 0.8996 [0.8938, 0.9055]”
diceas written: “Dice Score (Vessel Wall Segmentation)”0.9016CI 0.8962, 0.9070
source quote (p.14)
“Dice Score 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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251837