510(k) Report

FDA applicant

3Disc Americas

Naples, FL5 decisions2011–20150 recalls

FDA records 5 decisions for 3Disc Americas (Naples, FL) from 2011 to 2015: 5 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Its devices cite 5 predicates, 2 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 3Disc Americas’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2011: 12013: 12014: 22015: 1
2011high 2 (2014) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — 3Disc Americas by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)3decisions
  • LLZSystem, Image Processing, Radiological1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 2 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.

  • K102619Computed Raddiography Scanner3Disc Americas · 20113cite it
  • K131442Firecr Dentalimaging System3Disc Americas · 20132cite it

What has FDA decided for it lately?

  • K151687QuantorView3Disc Americas · 2015
  • K133106Computed Radiography Scanner3Disc Americas · 2014
  • K133120Computed Radiography Scanner3Disc Americas · 2014
  • K131442Firecr Dentalimaging System3Disc Americas · 2013
  • K102619Computed Raddiography Scanner3Disc Americas · 2011

All 5 as 3Disc Americas →