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ARIA Radiation Therapy Management
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ARIA Radiation Therapy Management 18.0Ref ARIA Radiation Therapy Management 16.1
Identity
- Trade Name
- ARIA Radiation Therapy Management EUDAMEDFDA UDIARIA Radiation Therapy Management (RTM) FDA UDI
- Generic Name
- Radiation therapy software FDA UDIRadiation therapy treatment record/verify system FDA UDI
- Device Name
- ARIA Radiation Therapy Management EUDAMED
- Model / Reference
- ARIA Radiation Therapy Management 18.0 EUDAMEDARIA Radiation Therapy Management 16.1 EUDAMED18.0 FDA UDI16.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006318 EUDAMEDFDA UDI00856100006165 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200119PV EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMED
- GMDN Term
- Radiation therapy software FDA UDIRadiation 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ARIA Radiation Therapy Management 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 | 089947500200119PV | 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 (4)
- EUDAMED 453350d6-757d-490b-9e06-b26ae822a028 61 fields · synced Oct 6, 2026
- FDA UDI 4a9b8bfd-74bb-460d-a275-6cfd5d4e6a34 33 fields · synced May 30, 2026
- FDA UDI 9c82588f-f8f1-47e2-b831-2e43256ddba0 33 fields · synced May 30, 2026
- EUDAMED 2fcd25ff-9895-4df7-9ef5-1ed3c6450495 61 fields · synced Jul 28, 2026