510(k) K163500 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
| Applicant | Ion Beam Applications S.A., Louvain-La-Neuve, BE |
| Decision | Substantially Equivalent, Aug 17, 2017 |
| Received | Dec 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163500
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Nov 29, 2021 | Ion Beam Applications S.A. Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Terminated |
LHN | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.