gudid
Primary ID: PROBEAT-FR
PROBEAT (UDI PROBEAT-FR)
Manufactured by HITACHI, LTD.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PROBEAT - Primary ID PROBEAT-FR
Device Regulatory Overview
The PROBEAT (Model/Catalog Number: PROBEAT-FR) is a medical device manufactured by HITACHI, LTD.. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PROBEAT-FR
- Product Code / EMDN
- LHN
- Device Name
- The PROBEAT-FR 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-FR is a modification to the cleared PROBEAT-CR system, for installation at a different clinical site.
- Database Sync Date
- 2026-08-09 09:15:39
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PROBEAT?
The registered manufacturer of record for PROBEAT is HITACHI, LTD..
What is the Primary UDI-DI identifier for PROBEAT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PROBEAT-FR.
What classification code is assigned to this device?
This device is registered under product classification code LHN.
Similar Classification Devices (LHN)
Other Devices by HITACHI, LTD.
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