510(k) Report

FDA applicant

Mediface Co., Ltd.

Aubrey, TX1 decision2001–20010 recalls

FDA records 1 decision for Mediface Co., Ltd. (Aubrey, TX) in 2001: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 Mediface Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mediface Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mediface Co., Ltd. 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

Who builds on its devices?

Later devices cite its devices 6 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.

  • K010259Mediface PacsMediface Co., Ltd. · 20016cite it

What has FDA decided for it lately?

  • K010259Mediface PacsMediface Co., Ltd. · 2001

The one decision as Mediface Co., Ltd. →