510(k) Report

FDA applicant

Aycan Digitalsysteme GmbH

Wuerzburg, DE3 decisions2007–20120 recalls

FDA records 3 decisions for Aycan Digitalsysteme GmbH (Wuerzburg, DE) from 2007 to 2012: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). 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 Aycan Digitalsysteme GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2007: 12011: 12012: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aycan Digitalsysteme GmbH by year, 2007–2026Sources: 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, Radiological3decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 4 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.

  • K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH · 20074cite it

What has FDA decided for it lately?

  • K122260Aycan MobileAycan Digitalsysteme GmbH · 2012
  • K103546Aycan Workstation Osirix ProAycan Digitalsysteme GmbH · 2011
  • K063470Aycan Workstation OsirixAycan Digitalsysteme GmbH · 2007

All 3 as Aycan Digitalsysteme GmbH →