510(k) Report

FDA applicant

American Science and Engineering, Inc.

Mchenry, IL3 decisions1976–19830 recalls

FDA records 3 decisions for American Science and Engineering, Inc. (Mchenry, IL) from 1976 to 1983: 3 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and JAK (System, X-Ray, Tomography, Computed). 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 American Science and Engineering, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Science and Engineering, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — American Science and Engineering, 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?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • IZFSystem, X-Ray, Tomographic1decision

What has FDA decided for it lately?

  • K833237Digital Radiography Sys Dual GantriesAmerican Science and Engineering, Inc. · 1983
  • K761004X-Ray Scanner, Whole Body, as&EAmerican Science and Engineering, Inc. · 1976
  • K760201X-Ray Scanner, Computerized TomographicAmerican Science and Engineering, Inc. · 1976

All 3 as American Science and Engineering, Inc. →