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ProBeam 360° Proton Theray System - Rotating Gantry 1.0
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref ProBeam 360° 1.0Ref ProBeam 360° 3.0
Identity
- Trade Name
- ProBeam 360° Proton Theray System - Rotating Gantry 1.0 EUDAMEDProBeam 360° Proton Therapy System - Rotating Gantry EUDAMEDProBeam 360 Proton Therapy System - Rotaiting Gantry FDA UDI
- Generic Name
- Proton therapy system FDA UDI
- Device Name
- ProBeam, ProBeam 360° EUDAMED
- Model / Reference
- ProBeam 360° 1.0 EUDAMEDProBeam 360° 3.0 EUDAMED1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858991006071 EUDAMEDFDA UDI00858991006194 EUDAMED
- Basic UDI-DI
- 089947500200101PA EUDAMED
- 510(k) Number
- K221791 FDA UDI
- FDA Product Code
- LHN FDA UDI
- EMDN Code
- Z11011001 PROTON THERAPY SYSTEMS EUDAMED
- GMDN Term
- Proton therapy system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ProBeam 360° Proton Theray System - Rotating Gantry 1.0 by Varian Medical Systems Particle Therapy GmbH & Co. KG — Class IIb — FDA_510K, MDR — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221791 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200101PA | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000005626
Sources (4)
- EUDAMED aa1e74c0-1a4a-4643-99b4-46d7118e94ce 61 fields · synced Oct 6, 2026
- FDA UDI 7d06968b-1d16-4d2f-9819-fc5a6378c381 33 fields · synced May 30, 2026
- EUDAMED 84b1a4b8-75c7-4289-bb60-4863144f195f 61 fields · synced Jul 30, 2026
- FDA 510(k) K221791 1 fields · synced May 18, 2026