IBA Proton Therapy System – Proteus 235

GUDID 05404013801138

Proton Therapy System

Ion Beam Applications SA

Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system

• Primary Device ID: 05404013801138
• NIH Device Record Key: 5f7f7467-12f8-49fc-b6ed-2c16efcee981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IBA Proton Therapy System – Proteus 235
• Version Model Number: Proteus PLUS/Proteus ONE
• Company DUNS: 372078154
• Company Name: Ion Beam Applications SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404013801138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163500

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-28

Devices Manufactured by Ion Beam Applications SA

• 05404013801138 - IBA Proton Therapy System – Proteus 235: 2021-03-08Proton Therapy System
• 05404013801138 - IBA Proton Therapy System – Proteus 235: 2021-03-08 Proton Therapy System
• 05404013802012 - I2C (IBA Image-Guided Therapy Console): 2020-08-17 Image-Guided Therapy Console
• 05404013834013 - I2C (IBA Image-Guided Therapy Console): 2020-02-11 Image-Guided Therapy Console
• 05404013831258 - I2C (IBA Image-Guided Therapy Console): 2019-10-04 Image-Guided Therapy Console
• 05404013831906 - I2C (IBA Image Guided Therapy Console): 2019-10-04 Image Guided Therapy Console
• 05404013814015 - Proteus 235: 2018-09-03 IBA Proton Therapy System – Proteus 235
• 05404013810901 - Proteus 235: 2018-03-29 IBA Proton Therapy System – Proteus 235
• 05404013813308 - Proteus 235: 2018-03-29 IBA Proton Therapy System – Proteus 235