510(k) Report

FDA applicant

Taiwan Electronic Data Processing Corporation

Denton, TX1 decision2002–20020 recalls

FDA records 1 decision for Taiwan Electronic Data Processing Corporation (Denton, TX) in 2002: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 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 Taiwan Electronic Data Processing Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taiwan Electronic Data Processing Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Taiwan Electronic Data Processing Corporation 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?

  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K022710SmartpacsTaiwan Electronic Data Processing Corporation · 20023cite it

What has FDA decided for it lately?

  • K022710SmartpacsTaiwan Electronic Data Processing Corporation · 2002

The one decision as Taiwan Electronic Data Processing Corporation →