IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)— 510(k) K163500

Clearance details

Applicant

Ion Beam Applications S.A.

Product code

Code LHN

Device class

Class 2

Regulation

21 CFR 892.5050

Advisory panel

Radiology

Date received

2016-12-13

Decision date

2017-08-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Louvain-La-Neuve, BE

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• Z-1497-2026 — IBA Proton Therapy System - PROTEUS 235Class II·Ongoing·Ion Beam Applications S.A.·20260203
• 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 radiationClass II·Ongoing·Ion Beam Applications S.A.·20240710
• 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 versionsClass II·Ongoing·Ion Beam Applications S.A.·20240708
• 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.Class II·Ongoing·Ion Beam Applications S.A.·20240510
• Z-1603-2024 — IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.Class II·Ongoing·Ion Beam Applications S.A.·20240304
• 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.Class II·Ongoing·Ion Beam Applications S.A.·20230918
• 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 radiationClass II·Ongoing·Ion Beam Applications S.A.·20220420
• 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 235Class II·Ongoing·Ion Beam Applications S.A.·20220215
• Z-0466-2022 — Proteus 235; Version: PTS-8 versions before PTS-8.7.2Class II·Terminated·Ion Beam Applications S.A.·20211129
• Z-2715-2020 — 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 localized tumors and other conditions susceptible to treatment by radiation.Class II·Terminated·Ion Beam Applications S.A.·20200717
• Z-2773-2020 — 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 localized tumors and other conditions susceptible to treatment by radiation.Class II·Terminated·Ion Beam Applications S.A.·20200421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163500.