510(k) Report

FDA applicant

Chung-Shan Institute of Science and Technology

Denton, TX1 decision2003–20030 recalls

FDA records 1 decision for Chung-Shan Institute of Science and Technology (Denton, TX) in 2003: 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 Chung-Shan Institute of Science and Technology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chung-Shan Institute of Science and Technology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chung-Shan Institute of Science and Technology 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:

What has FDA decided for it lately?

  • K0315673D Invivo by CsistChung-Shan Institute of Science and Technology · 2003

The one decision as Chung-Shan Institute of Science and Technology →

Other applicant names beginning “Chung-Shan”

FDA records each applicant name separately; these may or may not be the same firm.

Chung Shiang Rubber Industrial Co. 1Chung Yuan Rubber & Plastics Co. 1Chung Kuo Industrial Co., Ltd. 1Chung Cheng Electric Heating Co., Ltd. 1Chung Yuan Trading Co., Ltd. 1Chung Yang Rubber Works (M) Sdn. Bhd. 1