510(k) Report

FDA applicant

Nuclemed S.A.

Hudson, NH2 decisions2009–20090 recalls

FDA records 2 decisions for Nuclemed S.A. (Hudson, NH) in 2009: 2 510(k) clearances. Most are in product codes MUJ (System, Planning, Radiation Therapy Treatment) and HAW (Neurological Stereotaxic Instrument). Its devices cite 11 predicates, 0 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 Nuclemed S.A.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Nuclemed S.A. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MUJSystem, Planning, Radiation Therapy Treatment1decision
  • HAWNeurological Stereotaxic Instrument1decision

Whose devices does it build on?

Its devices cite 11 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K090190Win-Neus Stereotactic Surgery Treatment Planning SystemNuclemed S.A. · 2009
  • K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009

All 2 as Nuclemed S.A. →