510(k) Report

FDA applicant

Best Theratronics Limited

Ottawa, CA4 decisions2014–20190 recalls

FDA records 4 decisions for Best Theratronics Limited (Ottawa, CA) from 2014 to 2019: 4 510(k) clearances. Most are in product codes IWB (System, Radiation Therapy, Radionuclide) and MOT (Irradiator, Blood To Prevent Graft Versus Host…). Its devices cite 4 predicates, 1 of them its own earlier devices. 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 Best Theratronics Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12015: 12016: 12019: 1
2014high 1 (2014) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Best Theratronics Limited by year, 2014–2026Sources: 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, Radionuclide2decisions
  • MOTIrradiator, Blood To Prevent Graft Versus Host Disease2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161324Raycell Mk2Best Theratronics Limited · 20161cites it

What has FDA decided for it lately?

  • K181737Raycell MK1Best Theratronics Limited · 2019
  • K161324Raycell Mk2Best Theratronics Limited · 2016
  • K150191GammaBeam 500Best Theratronics Limited · 2015
  • K142219GammaBeam 100Best Theratronics Limited · 2014

All 4 as Best Theratronics Limited →