510(k) Report

FDA applicant

Ivs Solutions AG

Chemnitz, Saxony, DE1 decision2007–20072 recalls

FDA records 1 decision for Ivs Solutions AG (Chemnitz, Saxony, DE) in 2007: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Ivs Solutions AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ivs Solutions AG 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, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K071636Codiagnostix (R) 5.72Ivs Solutions AG · 20072cite it

What has FDA decided for it lately?

  • K071636Codiagnostix (R) 5.72Ivs Solutions AG · 20072 recalls

The one decision as Ivs Solutions AG →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K071636Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant…Aug 4, 2011
  • K071636Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including…Sep 30, 2010