510(k) Report

FDA applicant

Medimage, Inc.

Ann Arbor, MI3 decisions1992–19950 recalls

FDA records 3 decisions for Medimage, Inc. (Ann Arbor, MI) from 1992 to 1995: 3 510(k) clearances. All are in product code KPS (System, Tomography, Computed, Emission). 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 Medimage, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medimage, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medimage, 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?

  • KPSSystem, Tomography, Computed, Emission3decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K946334GALENMedimage, Inc. · 19951cites it

What has FDA decided for it lately?

  • K946334GALENMedimage, Inc. · 1995
  • K933321DeltamanagerMedimage, Inc. · 1993
  • K922303M-LINKMedimage, Inc. · 1992

All 3 as Medimage, Inc. →