510(k) Report

FDA applicant

Voxar Limited

Edinburgh, Lothian, GB4 decisions1999–20050 recalls

FDA records 4 decisions for Voxar Limited (Edinburgh, Lothian, GB) from 1999 to 2005: 4 510(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 Voxar Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Voxar Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Voxar Limited 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, Radiological4decisions

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 22 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.

  • K992654Plug 'N View 3D, Version 1.0Voxar Limited · 199916cite it
  • K012072Voxar VC, Model 1.0Voxar Limited · 20013cite it
  • K020140Voxar's Calcium Scoring ProductVoxar Limited · 20022cite it
  • K043194Voxar 3D Product FamilyVoxar Limited · 20051cites it

What has FDA decided for it lately?

  • K043194Voxar 3D Product FamilyVoxar Limited · 2005
  • K020140Voxar's Calcium Scoring ProductVoxar Limited · 2002
  • K012072Voxar VC, Model 1.0Voxar Limited · 2001
  • K992654Plug 'N View 3D, Version 1.0Voxar Limited · 1999

All 4 as Voxar Limited →