PROBEAT

GUDID 04560333350211

The PROBEAT-V 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 Mini Ridge Filter is an optional accessory to modify the beam of the PROBEAT-V system. As auxiliary functions, a beam gating function and a fluoroscopy function during proton beam irradiation are added.

HITACHI, LTD.

Proton therapy system

• Primary Device ID: 04560333350211
• NIH Device Record Key: b9b73cb3-efc5-4bf5-81fc-6fa9d8422327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBEAT
• Version Model Number: Mini Ridge Filter and auxiliary functions for PROB
• Company DUNS: 739444076
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560333350211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181676

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: 2023-12-28
• Device Publish Date: 2023-12-20

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