FDA applicant

Eemagine Medical Imaging Solutions GmbH

Berlin, DE8 decisions2000–20240 recalls

FDA records 8 decisions for Eemagine Medical Imaging Solutions GmbH (Berlin, DE) from 2000 to 2024: 8 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and OLX (Source Localization Software For…). Its devices cite 8 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, neurology panel, where it files most

How often FDA has decided Eemagine Medical Imaging Solutions GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eemagine Medical Imaging Solutions GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Eemagine Medical Imaging Solutions GmbH

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?