Identity
- Trade Name
- Radixact EUDAMEDRadixact™ Treatment Delivery System FDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- Radixact Treatment Delivery System EUDAMEDFDA UDI
- Model / Reference
- 1060000 EUDAMEDFDA UDI
- Description
- Radixact Treatment Delivery System FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00811376030009 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00811376030009 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010101 SINGLE ENERGY LINEAR ACCELERATORS EUDAMED
- GMDN Term
- Linear accelerator system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Belgium 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Radixact by Accuray Incorporated — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00811376030009 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Accuray Incorporated
- EUDAMED SRN
- US-MF-000010238
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e2ace9a4-be68-427a-8ecd-f766344b267c 61 fields · synced Jul 9, 2026
- FDA UDI c0e29cdd-62bd-4334-9488-5a311877b298 35 fields · synced May 30, 2026