510(k) Report

FDA applicant

Hinacom Software and Technology, Ltd.

Beijing, CN2 decisions2013–20180 recalls

FDA records 2 decisions for Hinacom Software and Technology, Ltd. (Beijing, CN) from 2013 to 2018: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 4 predicates, 1 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 Hinacom Software and Technology, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013: 12018: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Hinacom Software and Technology, Ltd. by year, 2013–2026Sources: 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, Radiological2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 20131cites it

What has FDA decided for it lately?

  • K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd. · 2018
  • K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd. · 2013

All 2 as Hinacom Software and Technology, Ltd. →