510(k) Report

FDA applicant

Medical Standard Co., Ltd.

Denton, TX3 decisions2003–20090 recalls

FDA records 3 decisions for Medical Standard Co., Ltd. (Denton, TX) from 2003 to 2009: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 2 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 Medical Standard Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K023460PacsplusMedical Standard Co., Ltd. · 20034cite it
  • K042311PacspartnerMedical Standard Co., Ltd. · 20043cite it

What has FDA decided for it lately?

  • K083658Pacs Plus 5TH EditionMedical Standard Co., Ltd. · 2009
  • K042311PacspartnerMedical Standard Co., Ltd. · 2004
  • K023460PacsplusMedical Standard Co., Ltd. · 2003

All 3 as Medical Standard Co., Ltd. →