510(k) Report

FDA applicant

Mitsmed Medical Instrument Technology Co., Ltd.

Hsin Chu City, TW1 decision2009–20090 recalls

FDA records 1 decision for Mitsmed Medical Instrument Technology Co., Ltd. (Hsin Chu City, TW) in 2009: 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 Mitsmed Medical Instrument Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Mitsmed Medical Instrument Technology Co., Ltd. by year, 2009–2026Sources: 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:

What has FDA decided for it lately?

  • K092581Mits Dicom Gateway and Image ManagerMitsmed Medical Instrument Technology Co., Ltd. · 2009

The one decision as Mitsmed Medical Instrument Technology Co., Ltd. →