510(k) Report

FDA applicant

Seibu Techno Coproration

Japan, JP1 decision1995–19950 recalls

FDA records 1 decision for Seibu Techno Coproration (Japan, JP) in 1995: 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 Seibu Techno Coproration’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Seibu Techno Coproration since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Seibu Techno Coproration by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Seibu Techno Coproration’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IXJGrid, Radiographic1decision

What has FDA decided for it lately?

  • K945697SK S-Ray GridsSeibu Techno Coproration · 1995

The one decision as Seibu Techno Coproration →