Ion Beam Applications S.A.

Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·April 30, 2014

Proton therapy system -Proteus 235 aka Proteus Plus. 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.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·May 24, 2017

Proteus 235, Proton Therapy System

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·April 26, 2017

Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·July 18, 2018

Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·July 25, 2018

Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·March 14, 2018

Proteus ONE and Proteus Plus

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·June 20, 2018

adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·December 31, 2014

Proteus 235 Proton Therapy System for cancer treatment.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·November 5, 2014

Proteus 235

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·April 5, 2017

Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·July 12, 2017

Proteus 235

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·June 28, 2017

Proteus 235 and Proteus ONE proton therapy systems

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·July 12, 2017

Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·March 21, 2018

Proteus 235, Uniform and Pencil Beam Scanning 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·March 21, 2018

12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·June 13, 2018

Proteus 235 The PTS 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·June 20, 2018

Proteus 235, graphite block 8

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·March 14, 2018

Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·May 2, 2018

The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

FDA Enforcement

Class II ·Terminated·Ion Beam Applications S.A.·July 4, 2018