510(k) Report

FDA applicant

Isodose Control B.V.

Veenendaal, NL4 decisions2007–20091 recall

FDA records 4 decisions for Isodose Control B.V. (Veenendaal, NL) from 2007 to 2009: 4 510(k) clearances. Most are in product codes JAQ (System, Applicator, Radionuclide…) and MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 13 predicates, 1 of them its own earlier devices. 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 Isodose Control B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 12008: 22009: 1
2007high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Isodose Control B.V. 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?

  • JAQSystem, Applicator, Radionuclide, Remote-Controlled2decisions
  • MUJSystem, Planning, Radiation Therapy Treatment2decisions

Whose devices does it build on?

Its devices cite 13 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K091145Flexiplan 3D and 3D+Isodose Control B.V. · 20091cites it
  • K081112Flexiplan Brachytherapy Treatment Planning SystemIsodose Control B.V. · 20081cites it

What has FDA decided for it lately?

  • K091145Flexiplan 3D and 3D+Isodose Control B.V. · 2009
  • K082530Applicators for Afterloading BrachytherapyIsodose Control B.V. · 2008
  • K081112Flexiplan Brachytherapy Treatment Planning SystemIsodose Control B.V. · 2008
  • K070574FlexitronIsodose Control B.V. · 20071 recall

All 4 as Isodose Control B.V. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070574There is a complaint regarding internal check cable guide mechanism failure for the…Nov 18, 2019Class II