Ion Beam Applications S.A.
Ion Beam Applications S.A. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2017, with 36 FDA device recalls on record.
Top product codes for Ion Beam Applications S.A.
FDA recalls by Ion Beam Applications S.A.
10 most recent of 36- Z-1497-2026 — IBA Proton Therapy System - PROTEUS 235
- Z-2693-2024 — 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
- Z-3089-2024 — IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
- Z-1945-2024 — 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.
- Z-1603-2024 — IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
- Z-0295-2024 — IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
- Z-1205-2022 — 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
- Z-0747-2022 — 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
- Z-0466-2022 — Proteus 235; Version: PTS-8 versions before PTS-8.7.2
- Z-2434-2021 — 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Ion Beam Applications S.A.
- K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
- K132919 — GANTRY BEAM LINE
- K132847 — I2C
- K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K100766 — IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235
- K092796 — IBA PROTON THERAPY SYSTEM, PROTEUS 235
- K091629 — PROTEUS 235 PROTON THERAPY SYSTEM
- K083058 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K082416 — IBA PROTON THERAPY SYSTEM- PROTEUS 235
- K061913 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K060695 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K053641 — IBA PROTON THERAPY SYSTEM-PROTEUS 235
- K983024 — PROTON THERAPY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.