510(k) Report

FDA applicant

Nucleushealth, LLC

San Diego, CA2 decisions2017–20201 recall

FDA records 2 decisions for Nucleushealth, LLC (San Diego, CA) from 2017 to 2020: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Nucleushealth, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2017: 12020: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2017high 1 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Nucleushealth, LLC by year, 2017–2026Sources: 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 2 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.

  • K203249Nucleus.ioNucleushealth, LLC · 20202cite it

What has FDA decided for it lately?

  • K203249Nucleus.ioNucleushealth, LLC · 20201 recall
  • K171130Nucleus Image Management SystemNucleushealth, LLC · 2017

All 2 as Nucleushealth, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K203249Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of…Nov 1, 2023Class II