510(k) Report

FDA applicant

Theratronics, Inc.

Kanata, Ontario, Canada, CA9 decisions1982–19984 recalls

FDA records 9 decisions for Theratronics, Inc. (Kanata, Ontario, Canada, CA) from 1982 to 1998: 9 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and IWB (System, Radiation Therapy, Radionuclide). Its devices cite 10 predicates, 5 of them its own earlier devices. 4 recalls are 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 Theratronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Theratronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Theratronics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Theratronics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical4decisions
  • IWBSystem, Radiation Therapy, Radionuclide3decisions
  • IPFStimulator, Muscle, Powered1decision
  • IWDDevice, Beam Limiting, Teletherapy, Radionuclide1decision

Whose devices does it build on?

Its devices cite 10 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 5 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.

  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 19973cite it
  • K940237Theraplan V05B/ TP-11 V09BTheratronics, Inc. · 19942cite it
  • K894165Theratron 1000Theratronics, Inc. · 19901cites it
  • K964606Theratron 780ETheratronics, Inc. · 19971cites it
  • K983917Theratron EliteTheratronics, Inc. · 19981cites it
  • K954679Theraplan PlusTheratronics, Inc. · 19961cites it

What has FDA decided for it lately?

  • K983917Theratron EliteTheratronics, Inc. · 19982 recalls
  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 1997
  • K964606Theratron 780ETheratronics, Inc. · 19971 recall
  • K964607Theraton 1000ETheratronics, Inc. · 19971 recall
  • K954679Theraplan PlusTheratronics, Inc. · 1996
  • K940237Theraplan V05B/ TP-11 V09BTheratronics, Inc. · 1994
  • K922276Therac 25Theratronics, Inc. · 1994
  • K894165Theratron 1000Theratronics, Inc. · 1990

All 9 as Theratronics, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K983917Theratron Elite 80 Cobalt RadiotherapyJul 8, 2004
  • K964607Theratron 1000E Cobalt RadiotherapyJul 8, 2004
  • K983917Theratron Elite 100 Cobalt RadiotherapyJul 8, 2004
  • K964606Theratron 780E Cobalt RadiotherapyJul 8, 2004