gudid
Primary ID: PROBEAT WITH MGCS
PROBEAT (UDI PROBEAT WITH MGCS)
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 PROBEAT WITH MGCS
Device Regulatory Overview
The PROBEAT (Model/Catalog Number: PROBEAT WITH MGCS) 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
- PROBEAT WITH MGCS
- Product Code / EMDN
- LHN
- Device Name
- The PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treabment.
- 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 PROBEAT WITH MGCS.
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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