FDA applicant

Neusoft Digital Medical Systems Co., Ltd.

Shenyang, Liaoning, CN4 decisions2002–20040 recalls

FDA records 4 decisions for Neusoft Digital Medical Systems Co., Ltd. (Shenyang, Liaoning, CN) from 2002 to 2004: 4 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LNH (System, Nuclear Magnetic Resonance Imaging). Its devices cite 4 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 Neusoft Digital Medical Systems Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neusoft Digital Medical Systems Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Neusoft”

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

Neusoft Medical Systems Co., Ltd. 23 Neusoft Positron Medical Systems Co., Ltd. 1

Neusoft Digital Medical Systems Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Neusoft”