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Varian Treatment
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref Varian Treatment 13.0
Identity
- Trade Name
- Varian Treatment EUDAMEDFDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Device Name
- Varian Treatment EUDAMED
- Model / Reference
- Varian Treatment 13.0 EUDAMED13.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856104006000 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200123PL EUDAMED
- 510(k) Number
- K151882 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMED
- GMDN Term
- Radiation therapy treatment record/verify system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Varian Treatment 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093967 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200123PL | Class IIb | Active |
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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 (3)
- EUDAMED 0b61e31c-1c93-4dc0-879c-daebb4d912d7 61 fields · synced Jul 23, 2026
- FDA UDI 3df333bf-6bf5-4979-8da4-2d616cb702c6 33 fields · synced May 30, 2026
- FDA 510(k) K093967 1 fields · synced May 18, 2026