11 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/CT systems.
FDA Enforcement
Class II
·Ongoing·GE Healthcare, LLC·August 17, 2022
IBA Proton Therapy System - PROTEUS 235
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 18, 2026
IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 18, 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.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 12, 2024
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
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·June 8, 2022
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·November 22, 2023
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·May 1, 2024
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
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·March 16, 2022
Proteus 235-Proton Therapy System
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 4, 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
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·September 15, 2021
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
FDA Enforcement
Class II
·Ongoing·Ion Beam Applications S.A.·August 28, 2024