Identity
- Trade Name
- PROBEAT FDA UDI
- Generic Name
- Proton therapy system FDA UDI
- 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. FDA UDI
- Model / Reference
- PROBEAT-FR FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560333350204 FDA UDI
- 510(k) Number
- K232032 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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- ProBeam Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KG · Class II
- PRONOVA SC360 — PRONOVA SOLUTIONS, LLC · Class II
- Proteus 235 — Ion Beam Applications SA · Class II
- Mevion Medical Systems — Mevion Medical Systems, Inc. · Class II
- 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 d2c1916f-ea74-44df-b2bd-94994663f3b9 34 fields · synced May 30, 2026