510(k) Report

FDA applicant

Volpara Health Technologies Limited

Wellington, NZ2 decisions2018–20210 recalls

FDA records 2 decisions for Volpara Health Technologies Limited (Wellington, NZ) from 2018 to 2021: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 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 Volpara Health Technologies Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Volpara Health Technologies Limited by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K182310Volpara Imaging SoftwareVolpara Health Technologies Limited · 20182cite it

What has FDA decided for it lately?

  • K211279Volpara Imaging SoftwareVolpara Health Technologies Limited · 2021
  • K182310Volpara Imaging SoftwareVolpara Health Technologies Limited · 2018

All 2 as Volpara Health Technologies Limited →