510(k) Report

FDA applicant

S.a.I.E.P. S.R.L.

Weatherford, OK2 decisions2003–20030 recalls

FDA records 2 decisions for S.a.I.E.P. S.R.L. (Weatherford, OK) in 2003: 2 510(k) clearances. All are in product code IXW (Processor, Radiographic-Film, Automatic). Its devices cite 2 predicates, 0 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, radiology panel, where it files most

How often FDA has decided S.a.I.E.P. S.R.L.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for S.a.I.E.P. S.R.L. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — S.a.I.E.P. S.R.L. 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?

  • IXWProcessor, Radiographic-Film, Automatic2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K023801Film Processor, Model Life Ray Pro 1000S.a.I.E.P. S.R.L. · 2003
  • K023825Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L. · 2003

All 2 as S.a.I.E.P. S.R.L. →