Identity
- Trade Name
- ProBeam® Fixed Beam Proton Therapy System FDA UDI
- Generic Name
- Proton therapy system FDA UDI
- Device Name
- Fixed Beam FDA UDI
- Model / Reference
- 3.5 FDA UDI
- Description
- Fixed Beam FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858991006026 FDA UDI
- 510(k) Number
- K133191 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
ProBeam® Fixed Beam Proton Therapy System by Varian Medical Systems Particle Therapy GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Proton therapy system.
- IBA Proton Therapy System – Proteus 235 — Ion Beam Applications SA · Class II
- PROBEAT — HITACHI, LTD. · Class II
- Proteus 235 — Ion Beam Applications SA · Class II
- PRONOVA SC360 — PRONOVA SOLUTIONS, LLC · Class II
- PROBEAT — HITACHI, LTD. · Class II
- PROBEAT — HITACHI, LTD. · Class II
- Proteus 235 — Ion Beam Applications SA · Class II
- Mevion Medical Systems — Mevion Medical Systems, Inc. · Class II
Cleared under the same submission
K133191 also covers:
- ProBeam Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KG
- ProBeam Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KG
- ProBeam® Rotating Gantry Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KG
- ProBeam® Rotating Gantry Proton Therapy System — Varian Medical Systems Particle Therapy GmbH & Co. KG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 68299ce8-4201-4f13-bb1d-6373edfaab0d 34 fields · synced May 30, 2026