510(k) Report

FDA applicant

Neurognostics, Inc.

Milwaukee, WI2 decisions2005–20050 recalls

FDA records 2 decisions for Neurognostics, Inc. (Milwaukee, WI) in 2005: 2 510(k) clearances. All are in product code LNH (System, Nuclear Magnetic Resonance Imaging). 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 Neurognostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neurognostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neurognostics, Inc. 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?

  • LNHSystem, Nuclear Magnetic Resonance Imaging2decisions

Who builds on its devices?

Later devices cite its devices 3 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.

  • K043290Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 20052cite it
  • K052571Mindstate Functional Data Acquisition Device (Fdad), Version 1.0Neurognostics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052571Mindstate Functional Data Acquisition Device (Fdad), Version 1.0Neurognostics, Inc. · 2005
  • K043290Mindstate Functional Data Acquisition Device, Version 1.0Neurognostics, Inc. · 2005

All 2 as Neurognostics, Inc. →