510(k) Report

FDA applicant

Ebm Technologies USA, LLC

Honolulu, HI1 decision2014–20140 recalls

FDA records 1 decision for Ebm Technologies USA, LLC (Honolulu, HI) in 2014: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 Ebm Technologies USA, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 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 — Ebm Technologies USA, 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, Radiological1decision

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.

  • K140399Ebm Ido ViewerEbm Technologies USA, LLC · 20142cite it

What has FDA decided for it lately?

  • K140399Ebm Ido ViewerEbm Technologies USA, LLC · 2014

The one decision as Ebm Technologies USA, LLC →