510(k) Report

FDA applicant

General Electrical Espanola, S.A.

Walker, MI1 decision1979–19791 recall

FDA records 1 decision for General Electrical Espanola, S.A. (Walker, MI) in 1979: 1 510(k) clearance. All are in product code KXJ (Table, Radiologic). 1 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 General Electrical Espanola, S.A.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Electrical Espanola, S.A. since 2007.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — General Electrical Espanola, S.A. 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?

  • KXJTable, Radiologic1decision

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.

  • K790692TelevixGeneral Electrical Espanola, S.A. · 19791cites it

What has FDA decided for it lately?

  • K790692TelevixGeneral Electrical Espanola, S.A. · 19791 recall

The one decision as General Electrical Espanola, S.A. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K790692Prestilix 1600X Prestilix system is a fully integrated remote controlled digital…Mar 29, 2019Class II