510(k) Report

FDA applicant

Mds Nordion

Ottawa, CA9 decisions2000–20062 recalls

FDA records 9 decisions for Mds Nordion (Ottawa, CA) from 2000 to 2006: 9 510(k) clearances. Most are in product codes MOT (Irradiator, Blood To Prevent Graft Versus Host…) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 10 predicates, 2 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Mds Nordion, Inc.”, “Mds Nordion AB”.

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 Mds Nordion’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mds Nordion since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mds Nordion 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?

  • MOTIrradiator, Blood To Prevent Graft Versus Host Disease3decisions
  • MUJSystem, Planning, Radiation Therapy Treatment3decisions
  • IWBSystem, Radiation Therapy, Radionuclide2decisions
  • JAICouch, Radiation Therapy, Powered1decision

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 2 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.

  • K011246DCM 1.0Mds Nordion · 20013cite it
  • K051065Raycell X-Ray Blood IrradiatorMds Nordion · 20052cite it
  • K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 20011cites it
  • K020971DCM 2.0Mds Nordion AB · 20021cites it

What has FDA decided for it lately?

  • K060870AvanzaMds Nordion · 2006
  • K053485Theratron Equinox, Models 80 CM and 100 CMMds Nordion, Inc. · 2006
  • K051065Raycell X-Ray Blood IrradiatorMds Nordion · 2005
  • K050963Gammacell 1000 Elite and Gammacell 3000 ElanMds Nordion · 2005
  • K032684RaycellMds Nordion · 2003
  • K020971DCM 2.0Mds Nordion AB · 2002
  • K010682Helax-TMS V 5.1 Radiation Therapy Treatment Planning SystemMds Nordion · 2001
  • K011246DCM 1.0Mds Nordion · 2001

All 7 as Mds Nordion →The one decision as Mds Nordion, Inc. →The one decision as Mds Nordion AB →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K001006Theratron 1000 Cobalt RadiotherapyJul 8, 2004
  • K001006Theratron 780C Cobalt RadiotherapyJul 8, 2004