510(k) Report

FDA applicant

Context Vision AB

Linkoping, SE2 decisions2000–20030 recalls

FDA records 2 decisions for Context Vision AB (Linkoping, SE) from 2000 to 2003: 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 Context Vision AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Context Vision AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Context Vision AB 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, Radiological2decisions

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 12 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.

  • K024028Sharp View Image Enhancement SystemContext Vision AB · 20037cite it
  • K993802Sharpview Image Enhancement SystemContext Vision AB · 20005cite it

What has FDA decided for it lately?

  • K024028Sharp View Image Enhancement SystemContext Vision AB · 2003
  • K993802Sharpview Image Enhancement SystemContext Vision AB · 2000

All 2 as Context Vision AB →