510(k) Report

FDA applicant

Hepatiq, LLC

Irvine, CA2 decisions2014–20160 recalls

FDA records 2 decisions for Hepatiq, LLC (Irvine, CA) from 2014 to 2016: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 1 predicate, 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 Hepatiq, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2014: 12016: 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 — Hepatiq, 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?

  • LLZSystem, Image Processing, Radiological2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K161188Hepatiq 1.1Hepatiq, LLC · 2016
  • K142891HepatiqHepatiq, LLC · 2014

All 2 as Hepatiq, LLC →