510(k) Report

FDA applicant

Ion Beam Application S.A.

Louvain-La-Neuve, BE1 decision2016–20167 recalls

FDA records 1 decision for Ion Beam Application S.A. (Louvain-La-Neuve, BE) in 2016: 1 510(k) clearance. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 2 predicates, 0 of them its own earlier devices. 7 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 Ion Beam Application S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

4in 2017

2016: 32017: 4
2016high 4 (2017) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Ion Beam Application S.A. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 0 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.

  • K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 20162cite it

What has FDA decided for it lately?

  • K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. · 20167 recalls

The one decision as Ion Beam Application S.A. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K152224Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System -…Nov 1, 2017Class II
  • K152224Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to…Apr 10, 2017Class II
  • K152224Proteus 235, Proton Therapy SystemMar 21, 2017Class II
  • K152224Proteus 235Feb 9, 2017Class II
  • K152224Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus…Dec 13, 2016Class II
  • K152224Proteus ONE and Proteus PlusSep 16, 2016Class II