510(k) Report

FDA applicant

Statlife

Villejuif, FR2 decisions2016–20180 recalls

FDA records 2 decisions for Statlife (Villejuif, FR) from 2016 to 2018: 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 Statlife’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2016: 12018: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Statlife by year, 2016–2026Sources: 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:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152009DENSEEMAMMO v1.0Statlife · 20161cites it

What has FDA decided for it lately?

  • K173574DenSeeMammoStatlife · 2018
  • K152009DENSEEMAMMO v1.0Statlife · 2016

All 2 as Statlife →