510(k) Report

FDA applicant

Qi Imaging, LLC

Redwood City, CA2 decisions2014–20150 recalls

FDA records 2 decisions for Qi Imaging, LLC (Redwood City, CA) from 2014 to 2015: 2 510(k) clearances. Most are in product codes JAK (System, X-Ray, Tomography, Computed) and LLZ (System, Image Processing, Radiological). Its devices cite 17 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 Qi Imaging, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Qi Imaging, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JAKSystem, X-Ray, Tomography, Computed1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 17 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130552CT Pulmonary AnalysisQi Imaging, LLC · 20141cites it
  • K151212Ziostation2Qi Imaging, LLC · 20151cites it

What has FDA decided for it lately?

  • K151212Ziostation2Qi Imaging, LLC · 2015
  • K130552CT Pulmonary AnalysisQi Imaging, LLC · 2014

All 2 as Qi Imaging, LLC →