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ARIA Radiation Therapy Management
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref ARIA Radiation Therapy Management 17.0
Identity
- Trade Name
- ARIA Radiation Therapy Management EUDAMEDARIA Radiation Therapy Management (RTM) FDA UDI
- Generic Name
- Radiation therapy treatment record/verify system FDA UDI
- Device Name
- ARIA Radiation Therapy Management EUDAMED
- Model / Reference
- ARIA Radiation Therapy Management 17.0 EUDAMED17.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856100006189 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200119PV EUDAMED
- 510(k) Number
- K173838 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
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 (2)
- EUDAMED b9adc478-fcec-477f-ba95-7bea7fcc39c6 61 fields · synced Oct 5, 2026
- FDA UDI 9ecbc7be-bf2e-4e87-a85a-f27f3a579381 33 fields · synced May 29, 2026