510(k) Report

FDA applicant

Amra Medical AB

Linkoping, SE2 decisions2018–20210 recalls

FDA records 2 decisions for Amra Medical AB (Linkoping, SE) from 2018 to 2021: 2 510(k) clearances. 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 Amra Medical AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2018: 12021: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Amra Medical AB by year, 2018–2026Sources: 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 Imaging2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K211983AMRA ProfilerAmra Medical AB · 20212cite it
  • K173749AMRA ProfilerAmra Medical AB · 20181cites it

What has FDA decided for it lately?

  • K211983AMRA ProfilerAmra Medical AB · 2021
  • K173749AMRA ProfilerAmra Medical AB · 2018

All 2 as Amra Medical AB →