510(k) Report

FDA applicant

X-Cel X-Ray Corp.

Crystal Lake, IL4 decisions1981–20000 recalls

FDA records 4 decisions for X-Cel X-Ray Corp. (Crystal Lake, IL) from 1981 to 2000: 4 510(k) clearances. Most are in product codes MUH (System, X-Ray, Extraoral Source, Digital) and KPR (System, X-Ray, Stationary). 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 X-Cel X-Ray Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for X-Cel X-Ray Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — X-Cel X-Ray Corp. 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?

  • MUHSystem, X-Ray, Extraoral Source, Digital1decision
  • KPRSystem, X-Ray, Stationary1decision
  • IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray1decision
  • 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.

  • K811230X-Cell X-Ray #'S P-75W/P-75MX-Cel X-Ray Corp. · 19811cites it

What has FDA decided for it lately?

  • K993958Idx-60 Intraoral X-RayX-Cel X-Ray Corp. · 2000
  • K930699M6-MX-Cel X-Ray Corp. · 1993
  • K871116X-Cel X-Ray Models ORT90W, ORT90M and ORT90RX-Cel X-Ray Corp. · 1987
  • K811230X-Cell X-Ray #'S P-75W/P-75MX-Cel X-Ray Corp. · 1981

All 4 as X-Cel X-Ray Corp. →