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 ID04560333350228
NIH Device Record Key9eb1e461-d7cc-4ae8-9da0-fddcf2f97ea0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROBEAT
Version Model NumberReal Time Image Gating System for Proton Beam Ther
Company DUNS739444076
Company NameHITACHI, LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560333350228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LHNSystem, Radiation Therapy, Charged-Particle, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

On-Brand Devices [PROBEAT]

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

Trademark Results [PROBEAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROBEAT
PROBEAT
90980369 not registered Live/Pending
Dermal Diagnostics Limited
2020-09-03
PROBEAT
PROBEAT
90156818 not registered Live/Pending
Dermal Diagnostics Limited
2020-09-03
PROBEAT
PROBEAT
76390015 3077044 Live/Registered
KABUSHIKI KAISHA HITACHI SEISAKUSHO
2002-04-02

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