Ion Beam Applications S.A.

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1497-2026Class IIIBA Proton Therapy System - PROTEUS 235February 3, 2026
Z-2693-2024Class IIIBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatJuly 10, 2024
Z-3089-2024Class IIIBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versiJuly 8, 2024
Z-1945-2024Class IIIBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treaMay 10, 2024
Z-1603-2024Class IIIBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.March 4, 2024
Z-0295-2024Class IIIBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSSSeptember 18, 2023
Z-1205-2022Class IIProteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patienApril 20, 2022
Z-0747-2022Class IIProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patieFebruary 15, 2022
Z-0466-2022Class IIProteus 235; Version: PTS-8 versions before PTS-8.7.2November 29, 2021
Z-2434-2021Class IIProteus 235- designed to produce and deliver a proton beam for the treatment of patients with localiJune 14, 2021
Z-2155-2021Class IIProteus 235-Proton Therapy SystemMay 26, 2021
Z-2715-2020Class IIProteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is July 17, 2020
Z-2773-2020Class IIProteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) isApril 21, 2020
Z-0698-2019Class IIProteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus anDecember 12, 2018
Z-2470-2018Class IIProteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product UsagJune 27, 2018
Z-2424-2018Class IIProteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce andMay 16, 2018
Z-1477-2018Class IIProteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patJanuary 26, 2018
Z-0934-2018Class IIProteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand nameDecember 5, 2017
Z-0938-2018Class IIProteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam fNovember 17, 2017
Z-0943-2018Class IIProteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 23November 1, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)August 17, 2017
K132919GANTRY BEAM LINEJuly 10, 2014
K132847I2CNovember 20, 2013
K101508MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235August 6, 2010
K100766IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235July 21, 2010
K092796IBA PROTON THERAPY SYSTEM, PROTEUS 235December 22, 2009
K091629PROTEUS 235 PROTON THERAPY SYSTEMAugust 11, 2009
K083058IBA PROTON THERAPY SYSTEM - PROTEUS 235April 15, 2009
K082416IBA PROTON THERAPY SYSTEM- PROTEUS 235December 12, 2008
K061913IBA PROTON THERAPY SYSTEM - PROTEUS 235July 28, 2006
K060695IBA PROTON THERAPY SYSTEM - PROTEUS 235April 11, 2006
K053641IBA PROTON THERAPY SYSTEM-PROTEUS 235January 24, 2006
K983024PROTON THERAPY SYSTEMJuly 12, 2001