510(k) Report

FDA applicant

Dexis, LLC

Orange, CA2 decisions2009–20090 recalls

FDA records 2 decisions for Dexis, LLC (Orange, CA) in 2009: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MUH (System, X-Ray, Extraoral Source, Digital). Its devices cite 4 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 Dexis, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Dexis, LLC by year, 2009–2026Sources: 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, Radiological1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K090458Dexis SensorDexis, LLC · 20097cite it

What has FDA decided for it lately?

  • K090431Dexis SoftwareDexis, LLC · 2009
  • K090458Dexis SensorDexis, LLC · 2009

All 2 as Dexis, LLC →