510(k) Report

FDA applicant

Medical Imaging Electronics America, Inc.

Elk Grove Village, IL1 decision1995–19950 recalls

FDA records 1 decision for Medical Imaging Electronics America, Inc. (Elk Grove Village, IL) in 1995: 1 510(k) clearance. 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 Medical Imaging Electronics America, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Imaging Electronics America, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Imaging Electronics America, 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, Emission1decision

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.

  • K953193Scintron IVMedical Imaging Electronics America, Inc. · 19951cites it

What has FDA decided for it lately?

  • K953193Scintron IVMedical Imaging Electronics America, Inc. · 1995

The one decision as Medical Imaging Electronics America, Inc. →