gudid
Primary ID: Small Field Applicator
PROBEAT (UDI Small Field Applicator)
Manufactured by HITACHI HIGH-TECH CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PROBEAT - Primary ID Small Field Applicator
Device Regulatory Overview
The PROBEAT (Model/Catalog Number: Small Field Applicator) is a medical device manufactured by HITACHI HIGH-TECH CORPORATION. This product is indexed under FDA Product Code / Category Classification LHN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Small Field Applicator
- Product Code / EMDN
- LHN
- Device Name
- 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.
- 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 HIGH-TECH CORPORATION.
What is the Primary UDI-DI identifier for PROBEAT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Small Field Applicator.
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 HIGH-TECH CORPORATION
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