510(k) Report

FDA applicant

Softneta Uab

Kaunas, LT2 decisions2016–20220 recalls

FDA records 2 decisions for Softneta Uab (Kaunas, LT) from 2016 to 2022: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). 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 Softneta Uab’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12022: 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 — Softneta Uab 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

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K222320MedDreamSoftneta Uab · 20221cites it
  • K162011MedDreamSoftneta Uab · 20161cites it

What has FDA decided for it lately?

  • K222320MedDreamSoftneta Uab · 2022
  • K162011MedDreamSoftneta Uab · 2016

All 2 as Softneta Uab →