510(k) Report

FDA applicant

Ib Lab GmbH

Vienna, AT2 decisions2019–20230 recalls

FDA records 2 decisions for Ib Lab GmbH (Vienna, AT) from 2019 to 2023: 2 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and 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 Ib Lab GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2019: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Ib Lab GmbH by year, 2019–2026Sources: 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 Software1decision
  • LLZSystem, Image Processing, Radiological1decision

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 5 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.

  • K192109KOALAIb Lab GmbH · 20194cite it
  • K223646IB Lab LAMAIb Lab GmbH · 20231cites it

What has FDA decided for it lately?

All 2 as Ib Lab GmbH →