510(k) Report

FDA applicant

Aecl Medical

Kanata, Ontario, Canada, CA1 decision1986–19861 recall

FDA records 1 decision for Aecl Medical (Kanata, Ontario, Canada, CA) in 1986: 1 510(k) clearance. All are in product code IWB (System, Radiation Therapy, Radionuclide). 1 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 Aecl Medical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aecl Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aecl Medical 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?

  • IWBSystem, Radiation Therapy, Radionuclide1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K863180Theratron-PhoenixAecl Medical · 19862cite it

What has FDA decided for it lately?

  • K863180Theratron-PhoenixAecl Medical · 19861 recall

The one decision as Aecl Medical →

What has been recalled?

1 recall linked to its devices; the latest:

  • K863180Theratron Phoenix Cobalt RadiotherapyJul 8, 2004