510(k) Report

FDA applicant

Artrya Limited

Perth, AU2 decisions2025–20250 recalls

FDA records 2 decisions for Artrya Limited (Perth, AU) in 2025: 2 510(k) clearances. All are in product code QIH (Automated Radiological Image Processing Software). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Artrya Limited’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 2
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Artrya Limited by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K243038Salix CentralArtrya Limited · 20251cites it

What has FDA decided for it lately?

  • K251837Salix Coronary Plaque (V1.0.0)Artrya Limited · 2025
  • K243038Salix CentralArtrya Limited · 2025

All 2 as Artrya Limited →