← Back to catalogue
VitalBeam
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref VitalBeam 4.1510(k) K172013
Identity
- Trade Name
- VitalBeam EUDAMEDFDA UDI
- Generic Name
- Linear accelerator system FDA UDI
- Device Name
- TrueBeam-TrueBeam STx-Edge and VitalBeam EUDAMED
- Model / Reference
- VitalBeam 4.1 EUDAMED4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858086006849 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200122PJ EUDAMED
- Direct Marketing DI
- 00858086006849 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
VitalBeam by Varian Medical Systems, Inc. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K172013 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K150706 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200122PJ | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED a6c25b31-9477-4084-a693-a9f79a61d1bd 85 fields · synced Jun 18, 2026
- FDA UDI 4e5c9926-7b6f-400d-82db-083e976b3900 33 fields · synced May 30, 2026
- FDA 510(k) K172013 1 fields · synced May 18, 2026