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. 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. FDA UDI
- Model / Reference
- Small Field Applicator 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. 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560333350198 FDA UDI
- 510(k) Number
- K220883 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
Yes
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 b3149231-b303-48df-b791-1f0a3675d41c 34 fields · synced May 30, 2026