510(k) Report

FDA applicant

Mevisys Co., Ltd.

Denton, TX2 decisions2002–20050 recalls

FDA records 2 decisions for Mevisys Co., Ltd. (Denton, TX) from 2002 to 2005: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 Mevisys Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Mevisys Co., Ltd.’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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 1 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.

  • K022692Voxelplus PacsMevisys Co., Ltd. · 20024cite it
  • K050033LucionMevisys Co., Ltd. · 20051cites it

What has FDA decided for it lately?

  • K050033LucionMevisys Co., Ltd. · 2005
  • K022692Voxelplus PacsMevisys Co., Ltd. · 2002

All 2 as Mevisys Co., Ltd. →