510(k) Report

FDA applicant

Medison Radiology Systems, Inc.

Glenview, IL2 decisions2000–20000 recalls

FDA records 2 decisions for Medison Radiology Systems, Inc. (Glenview, IL) in 2000: 2 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and IZL (System, X-Ray, Mobile). 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 Medison Radiology Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medison Radiology Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medison Radiology Systems, 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
  • IZLSystem, X-Ray, Mobile1decision

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.

  • K993896Mca-601, C-Arm MobileMedison Radiology Systems, Inc. · 20001cites it

What has FDA decided for it lately?

  • K002685Cordless Compact Mobile X-Ray SystemMedison Radiology Systems, Inc. · 2000
  • K993896Mca-601, C-Arm MobileMedison Radiology Systems, Inc. · 2000

All 2 as Medison Radiology Systems, Inc. →

Other applicant names beginning “Medison”

FDA records each applicant name separately; these may or may not be the same firm.

Medison Co., Ltd. 24Medison America, Inc. 21