PROBEAT

GUDID 04560333350006

The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site.

HITACHI, LTD.

Proton therapy system

• Primary Device ID: 04560333350006
• NIH Device Record Key: d5245a33-92ee-43c0-920d-9d1e717422b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBEAT
• Version Model Number: PROBEAT-CR
• Company DUNS: 695377218
• Company Name: HITACHI, LTD.
• 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	04560333350006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191801

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: 2019-10-02
• Device Publish Date: 2019-09-24

On-Brand Devices [PROBEAT]

• 04560333350006: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for
• 04560333350198: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for
• 04560333350228: The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compa
• 04560333350211: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for
• 04560333350204: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for