FDA applicant

General Equipment For Medical Imaging, S.A.

Valencia, ES4 decisions2009–20230 recalls

FDA records 4 decisions for General Equipment For Medical Imaging, S.A. (Valencia, ES) from 2009 to 2023: 4 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and IYX (Camera, Scintillation (Gamma)). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “General Equipment For Medical Imaging”.

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 General Equipment For Medical Imaging, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — General Equipment For Medical Imaging, S.A. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like General Equipment For Medical Imaging…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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General Equipment For Medical Imaging, S.A.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?