Identity
- Trade Name
- PROBEAT FDA UDI
- Generic Name
- Proton therapy system FDA UDI
- 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. The Mini Ridge Filter is an optional accessory to modify the beam of the PROBEAT-V system. As auxiliary functions, a beam gating function and a fluoroscopy function during proton beam irradiation are added. FDA UDI
- Model / Reference
- Mini Ridge Filter and auxiliary functions for PROBEAT-V FDA UDI
- Description
- 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. The Mini Ridge Filter is an optional accessory to modify the beam of the PROBEAT-V system. As auxiliary functions, a beam gating function and a fluoroscopy function during proton beam irradiation are added. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560333350211 FDA UDI
- 510(k) Number
- K181676 FDA UDI
- FDA Product Code
- LHN FDA UDI
- GMDN Term
- Proton therapy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Proton therapy system
Probeat by Hitachi, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Proteus 235 — Ion Beam Applications SA · Class II
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- ProNova SC360 — PRONOVA SOLUTIONS, LLC · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hitachi, Ltd.
Sources (1)
- FDA UDI b9b73cb3-efc5-4bf5-81fc-6fa9d8422327 34 fields · synced Jun 8, 2026