Ion Beam Applications S.A.
FDA Regulatory Profile
Ion Beam Applications S.A. appears in FDA public data with 36 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1497-2026, Class II) was initiated on February 3, 2026. Its most recent 510(k) clearance was granted on August 17, 2017.
Summary
- Total Recalls
- 36
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1497-2026 | Class II | IBA Proton Therapy System - PROTEUS 235 | February 3, 2026 |
| Z-2693-2024 | Class II | IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treat | July 10, 2024 |
| Z-3089-2024 | Class II | IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versi | July 8, 2024 |
| Z-1945-2024 | Class II | IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the trea | May 10, 2024 |
| Z-1603-2024 | Class II | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. | March 4, 2024 |
| Z-0295-2024 | Class II | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS | September 18, 2023 |
| Z-1205-2022 | Class II | Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patien | April 20, 2022 |
| Z-0747-2022 | Class II | ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patie | February 15, 2022 |
| Z-0466-2022 | Class II | Proteus 235; Version: PTS-8 versions before PTS-8.7.2 | November 29, 2021 |
| Z-2434-2021 | Class II | Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with locali | June 14, 2021 |
| Z-2155-2021 | Class II | Proteus 235-Proton Therapy System | May 26, 2021 |
| Z-2715-2020 | Class II | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is | July 17, 2020 |
| Z-2773-2020 | Class II | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is | April 21, 2020 |
| Z-0698-2019 | Class II | Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus an | December 12, 2018 |
| Z-2470-2018 | Class II | Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usag | June 27, 2018 |
| Z-2424-2018 | Class II | Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and | May 16, 2018 |
| Z-1477-2018 | Class II | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of pat | January 26, 2018 |
| Z-0934-2018 | Class II | Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand name | December 5, 2017 |
| Z-0938-2018 | Class II | Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam f | November 17, 2017 |
| Z-0943-2018 | Class II | Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 23 | November 1, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163500 | IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | August 17, 2017 |
| K132919 | GANTRY BEAM LINE | July 10, 2014 |
| K132847 | I2C | November 20, 2013 |
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 | August 6, 2010 |
| K100766 | IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 | July 21, 2010 |
| K092796 | IBA PROTON THERAPY SYSTEM, PROTEUS 235 | December 22, 2009 |
| K091629 | PROTEUS 235 PROTON THERAPY SYSTEM | August 11, 2009 |
| K083058 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | April 15, 2009 |
| K082416 | IBA PROTON THERAPY SYSTEM- PROTEUS 235 | December 12, 2008 |
| K061913 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | July 28, 2006 |
| K060695 | IBA PROTON THERAPY SYSTEM - PROTEUS 235 | April 11, 2006 |
| K053641 | IBA PROTON THERAPY SYSTEM-PROTEUS 235 | January 24, 2006 |
| K983024 | PROTON THERAPY SYSTEM | July 12, 2001 |