PROBEAT

GUDID 04560333350198

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. Small Field Applicator is an optional accessory to the proton beam therapy system which can be added to the nozzle configuration of the cleared PROBEAT-V system to make the lateral penumbra sharp, as needed. The Small Field Applicator may be used in place of the optional removable Applicator having an aperture (collimator) that has been cleared as part of the PROBEAT-V system.

HITACHI, LTD.

Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system Proton therapy system

• Primary Device ID: 04560333350198
• NIH Device Record Key: b3149231-b303-48df-b791-1f0a3675d41c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBEAT
• Version Model Number: Small Field Applicator for PROBEAT-V
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560333350198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220883

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: 2023-10-10
• Device Publish Date: 2023-10-02

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