FDA applicant

Dexin Medical Imaging Technology Co., Ltd.

Weinan Hign-Tech Zone, CN1 decision2015–20150 recalls

FDA records 1 decision for Dexin Medical Imaging Technology Co., Ltd. (Weinan Hign-Tech Zone, CN) in 2015: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 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 Dexin Medical Imaging Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Dexin Medical Imaging Technology Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Dexin”

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

Dexin Pty., Ltd. 1

Dexin Medical Imaging Technology Co., Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Dexin”