510(k) Report

FDA applicant

3Mensio Medical Imaging BV

Denton, TX2 decisions2004–20080 recalls

FDA records 2 decisions for 3Mensio Medical Imaging BV (Denton, TX) from 2004 to 2008: 2 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 1 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 3Mensio Medical Imaging BV’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 3Mensio Medical Imaging BV by year, 2007–2026Sources: 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 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K0726533VISEON/Surgery3Mensio Medical Imaging BV · 20082cite it
  • K0430973VISEON3Mensio Medical Imaging BV · 20041cites it

What has FDA decided for it lately?

  • K0726533VISEON/Surgery3Mensio Medical Imaging BV · 2008
  • K0430973VISEON3Mensio Medical Imaging BV · 2004

All 2 as 3Mensio Medical Imaging BV →