510(k) Report

FDA applicant

Smit Rontgen

Md Eindhoven, NL1 decision1996–19960 recalls

FDA records 1 decision for Smit Rontgen (Md Eindhoven, NL) in 1996: 1 510(k) clearance. All are in product code IXJ (Grid, Radiographic). 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 Smit Rontgen’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Smit Rontgen since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Smit Rontgen 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?

  • IXJGrid, Radiographic1decision

What has FDA decided for it lately?

  • K963893Fibre Interspaced X-Ray GridSmit Rontgen · 1996

The one decision as Smit Rontgen →