Salix Central

K243038

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Salix Central is a web-based software application, hosted on AWS cloud services, delivered using a SaaS model.”
Algorithmmachine learning (ML) 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: Calcium Scoring (Pearson Correlation); Centerline Extraction (True Placement Percentage); 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 (3 observations)

f1as written: “F1 Score for Vessel Labelling”78.4CI [96.1%, 80.5%]
source quote (p.10)
“Vessel Labelling F1 Score 78.4% [96.1%, 80.5%]”
diceas written: “Dice Score for Lumen Wall Segmentation”0.8996CI (0.8938, 0.9055)
source quote (p.10)
“Lumen Wall Segmentation Dice Score 0.8996 (0.8938, 0.9055)”
diceas written: “Dice Score for Vessel Wall Segmentation”0.9016CI (0.8962, 0.9070)
source quote (p.10)
“Vessel Wall Segmentation 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/K243038