Identity
- Trade Name
- TrueBeam STx EUDAMEDFDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- TrueBeam-TrueBeam STx-Edge and VitalBeam EUDAMED
- Model / Reference
- TrueBeam STx 4.1 EUDAMED4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006863 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200122PJ EUDAMED
- Direct Marketing DI
- 00858086006863 EUDAMED
- 510(k) Number
- K232870 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010103 MULTI AND HIGH 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
- Netherlands 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
TrueBeam STx by Varian Medical Systems, Inc — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500200122PJ | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED cab62e56-ab0e-4535-9c34-cf348dbebbbb 61 fields · synced Jul 10, 2026
- FDA UDI 9ea1b10a-6d9b-4a52-ad14-9d373196317f 33 fields · synced May 30, 2026