I2C (IBA Image-Guided Therapy Console)

GUDID 05404013802012

Image-Guided Therapy Console

Ion Beam Applications SA

Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager Radiation therapy digital imager

• Primary Device ID: 05404013802012
• NIH Device Record Key: 8ce768b3-526f-494b-9393-891e9d68a7b1
• 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	05404013802012 [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: 2020-08-17
• Device Publish Date: 2020-08-09

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

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• 05404013830534: Image-Guided Therapy Console
• 05404013831258: Image-Guided Therapy Console
• 05404013834013: Image-Guided Therapy Console
• 05404013802012: Image-Guided Therapy Console