FDA applicant

Viztek, LLC

Naples, FL11 decisions2001–20160 recalls

FDA records 11 decisions for Viztek, LLC (Naples, FL) from 2001 to 2016: 11 510(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 16 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Viztek, Inc.”.

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 Viztek, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Viztek, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Viztek, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?