510(k) Report

FDA applicant

Vitel Net

Mclean, VA2 decisions2000–20040 recalls

FDA records 2 decisions for Vitel Net (Mclean, VA) from 2000 to 2004: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQA (Oximeter). Its devices cite 1 predicate, 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 Vitel Net’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vitel Net since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vitel Net 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, Radiological1decision
  • DQAOximeter1decision

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.

  • K040581Medvizertm Vitelcare Patient Monitoring SystemVitel Net · 20042cite it
  • K000557Medvizer Pacs, Model Release 2000Vitel Net · 20001cites it

What has FDA decided for it lately?

  • K040581Medvizertm Vitelcare Patient Monitoring SystemVitel Net · 2004
  • K000557Medvizer Pacs, Model Release 2000Vitel Net · 2000

All 2 as Vitel Net →