I2C (IBA Image Guided Therapy Console) NA

GUDID 05404013831906

Image Guided Therapy Console

Ion Beam Applications SA

Radiation therapy digital imager

• Primary Device ID: 05404013831906
• NIH Device Record Key: e5b598f6-1e43-4aab-95ff-e5a5a362ec57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I2C (IBA Image Guided Therapy Console)
• Version Model Number: adaPTinsight
• Catalog Number: NA
• 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	05404013831906 [Primary]

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: 2019-10-04
• Device Publish Date: 2019-09-26

Devices Manufactured by Ion Beam Applications SA

• 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): 2019-10-04Image 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