510(k) Report

FDA applicant

Ekeroth Quality AB

Stockholm, SE1 decision1999–19990 recalls

FDA records 1 decision for Ekeroth Quality AB (Stockholm, SE) in 1999: 1 510(k) clearance. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 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 Ekeroth Quality AB’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ekeroth Quality AB since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ekeroth Quality 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K992120Dynawell or DynawellEkeroth Quality AB · 19991cites it

What has FDA decided for it lately?

  • K992120Dynawell or DynawellEkeroth Quality AB · 1999

The one decision as Ekeroth Quality AB →