510(k) Report

FDA applicant

Simuplan S.L.

Rice Lake, WI3 decisions2003–20120 recalls

FDA records 3 decisions for Simuplan S.L. (Rice Lake, WI) from 2003 to 2012: 3 510(k) clearances. All are in product code MUJ (System, Planning, Radiation Therapy Treatment). Its devices cite 4 predicates, 2 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 Simuplan S.L.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2009: 12012: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 2 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.

  • K093391Simuplan Treatment Planning SystemSimuplan S.L. · 20091cites it
  • K030821Simuplan Treatment Planning System, Model V. 7.5Simuplan S.L. · 20031cites it

What has FDA decided for it lately?

  • K120551Simuplan Treatment Planning SystemSimuplan S.L. · 2012
  • K093391Simuplan Treatment Planning SystemSimuplan S.L. · 2009
  • K030821Simuplan Treatment Planning System, Model V. 7.5Simuplan S.L. · 2003

All 3 as Simuplan S.L. →