Company · US

Ion Beam Applications S.A.

FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2017. Name variants (Inc, Corp, punctuation) are merged.

13510(k) clearances (0 in 12 months)

36recalls (1 in 12 months)

36recalls that name a 510(k)

Product codes

Code	Device	Records
LHN	System, Radiation Therapy, Charged-Particle, Medical	48
IYE	Accelerator, Linear, Medical	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Aug 17, 2017	K163500	IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A., BE	LHN
Jul 10, 2014	K132919	GANTRY BEAM LINE Ion Beam Applications S.A.	LHN
Nov 20, 2013	K132847	I2C Ion Beam Applications S.A.	LHN
Aug 6, 2010	K101508	MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A.	LHN
Jul 21, 2010	K100766	IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 Ion Beam Applications S.A.	LHN
Dec 22, 2009	K092796	IBA PROTON THERAPY SYSTEM, PROTEUS 235 Ion Beam Applications S.A.	LHN
Aug 11, 2009	K091629	PROTEUS 235 PROTON THERAPY SYSTEM Ion Beam Applications S.A., BE	LHN
Apr 15, 2009	K083058	IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A.	LHN
Dec 12, 2008	K082416	IBA PROTON THERAPY SYSTEM- PROTEUS 235 Ion Beam Applications S.A.	LHN
Jul 28, 2006	K061913	IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A.	LHN
Apr 11, 2006	K060695	IBA PROTON THERAPY SYSTEM - PROTEUS 235 Ion Beam Applications S.A.	LHN
Jan 24, 2006	K053641	IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A.	LHN
Jul 12, 2001	K983024	PROTON THERAPY SYSTEM Ion Beam Applications S.A.	LHN

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Mar 6, 2026	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235 Open, Classified	LHN	K163500
Sep 10, 2024	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions Open, Classified	LHN	K163500
Aug 21, 2024	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Open, Classified	LHN	K163500
Jun 3, 2024	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Open, Classified	LHN	K163500
Apr 19, 2024	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. Open, Classified	LHN	K163500
Nov 14, 2023	Ion Beam Applications S.A. IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System. Open, Classified	LHN	K163500
May 27, 2022	Ion Beam Applications S.A. Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Open, Classified	LHN	K163500
Feb 15, 2022	Ion Beam Applications S.A. ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235 Open, Classified	LHN	K163500
Nov 29, 2021	Ion Beam Applications S.A. Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Terminated	LHN	K163500
Sep 8, 2021	Ion Beam Applications S.A. Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Open, Classified	LHN	K061913
May 26, 2021	Ion Beam Applications S.A. Proteus 235-Proton Therapy System Open, Classified	LHN	K101508
Jul 17, 2020	Ion Beam Applications S.A. Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with loc Terminated	LHN	K163500
Apr 21, 2020	Ion Beam Applications S.A. Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with lo Terminated	LHN	K163500
Dec 12, 2018	Ion Beam Applications S.A. Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of p Terminated	LHN	K091629
Jun 27, 2018	Ion Beam Applications S.A. Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized Terminated	LHN	K060695
Jun 20, 2018	Ion Beam Applications S.A. Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions suscept Terminated	LHN	K101508
Jan 26, 2018	Ion Beam Applications S.A. Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Terminated	LHN	K101508
Dec 5, 2017	Ion Beam Applications S.A. Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for Terminated	LHN	K060695
Nov 17, 2017	Ion Beam Applications S.A. Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by Terminated	LHN	K101508
Nov 1, 2017	Ion Beam Applications S.A. Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a pr Terminated	LHN	K152224
Oct 19, 2017	Ion Beam Applications S.A. Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton Terminated	LHN	K082416
Oct 17, 2017	Ion Beam Applications S.A. Proteus 235, graphite block 8 Terminated	LHN	K101508
Jun 19, 2017	Ion Beam Applications S.A. Proteus 235 Terminated	LHN	K152224
May 3, 2017	Ion Beam Applications S.A. Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptibl Terminated	LHN	K152224
Mar 23, 2017	Ion Beam Applications S.A. Proteus 235 Terminated	LHN	K101508
Mar 21, 2017	Ion Beam Applications S.A. Proteus 235, Proton Therapy System Terminated	LHN	K152224
Dec 13, 2016	Ion Beam Applications S.A. Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with local Terminated	LHN	K152224
Oct 28, 2016	Ion Beam Applications S.A. 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respec Terminated	LHN	K132847
Sep 16, 2016	Ion Beam Applications S.A. Proteus ONE and Proteus Plus Terminated	LHN	K152224
Sep 16, 2016	Ion Beam Applications S.A. 12C Terminated	LHN	K132847
Aug 7, 2016	Ion Beam Applications S.A. Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Terminated	LHN	K132919
May 18, 2016	Ion Beam Applications S.A. Proteus 235 and Proteus ONE proton therapy systems Terminated	LHN	K132919
Apr 11, 2016	Ion Beam Applications S.A. The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS) Terminated	LHN	K152224
Dec 19, 2014	Ion Beam Applications S.A. adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therap Terminated	LHN	K132847
Oct 29, 2014	Ion Beam Applications S.A. Proteus 235 Proton Therapy System for cancer treatment. Terminated	IYE	K082416
Apr 24, 2014	Ion Beam Applications S.A. Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy Terminated	LHN	K082416

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