PROBEAT

GUDID 04560333350228

The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

HITACHI, LTD.

Proton therapy system

• Primary Device ID: 04560333350228
• NIH Device Record Key: 9eb1e461-d7cc-4ae8-9da0-fddcf2f97ea0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROBEAT
• Version Model Number: Real Time Image Gating System for Proton Beam Ther
• 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	04560333350228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171049

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