I2C (IBA Image-Guided Therapy Console)

GUDID 05404013831258

Image-Guided Therapy Console

Ion Beam Applications SA

Radiation therapy digital imager

• Primary Device ID: 05404013831258
• NIH Device Record Key: 0d3627f4-19c9-4bda-9595-85a97b0cba7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I2C (IBA Image-Guided Therapy Console)
• Version Model Number: adaPTinsight
• 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	05404013831258 [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

On-Brand Devices [I2C (IBA Image-Guided Therapy Console)]

• 05404013833313: Image-Guided Therapy Console
• 05404013830923: Image-Guided Therapy Console
• 05404013830916: Image-Guided Therapy Console
• 05404013830909: Image-Guided Therapy Console
• 05404013830626: Image-Guided Therapy Console
• 05404013830534: Image-Guided Therapy Console
• 05404013831258: Image-Guided Therapy Console
• 05404013834013: Image-Guided Therapy Console
• 05404013802012: Image-Guided Therapy Console