510(k) Report

FDA applicant

Ion Beam Applications S.A.

Philadelphia, PA13 decisions2001–201729 recalls

FDA records 13 decisions for Ion Beam Applications S.A. (Philadelphia, PA) from 2001 to 2017: 13 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 17 predicates, 7 of them its own earlier devices. 29 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 Applications S.A.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2008: 12009: 32010: 22013: 12014: 12017: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2013: 12014: 22016: 42017: 52018: 42020: 22021: 32022: 22023: 12024: 42026 (partial year): 1
2007high 5 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Ion Beam Applications S.A.’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?

  • LHNSystem, Radiation Therapy, Charged-Particle, Medical13decisions

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 7 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.

  • K983024Proton Therapy SystemIon Beam Applications S.A. · 20018cite it
  • K060695Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 20063cite it
  • K082416Iba Proton Therapy System- Proteus 235Ion Beam Applications S.A. · 20083cite it
  • K053641Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 20062cite it
  • K101508Modification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 20101cites it
  • K083058Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 20091cites it

What has FDA decided for it lately?

  • K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A. · 201711 recalls
  • K132919Gantry Beam LineIon Beam Applications S.A. · 20142 recalls
  • K132847I2CIon Beam Applications S.A. · 20133 recalls
  • K101508Modification to Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 20106 recalls
  • K100766Iba Proton Therapy System, Model Proteus 235Ion Beam Applications S.A. · 2010
  • K092796Iba Proton Therapy System, Proteus 235Ion Beam Applications S.A. · 2009
  • K091629Proteus 235 Proton Therapy SystemIon Beam Applications S.A. · 20091 recall
  • K083058Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2009

All 13 as Ion Beam Applications S.A. →

What has been recalled?

29 recalls linked to its devices; the latest:

  • K163500IBA Proton Therapy System - PROTEUS 235Feb 3, 2026Class II
  • K163500IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam…Jul 10, 2024Class II
  • K163500IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions…Jul 8, 2024Class II
  • K163500IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam…May 10, 2024Class II
  • K163500IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12…Mar 4, 2024Class II
  • K163500IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS…Sep 18, 2023Class II