510(k) Report

FDA applicant

Dalian Senyint Digital Medical System Co., Ltd.

Dalian, CN2 decisions2014–20180 recalls

FDA records 2 decisions for Dalian Senyint Digital Medical System Co., Ltd. (Dalian, CN) from 2014 to 2018: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). 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 Dalian Senyint Digital Medical System Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2014: 12018: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Dalian Senyint Digital Medical System Co., Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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