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Eclipse Treatment Planning System
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Eclipse Treatment Planning System 18.0
Identity
- Trade Name
- Eclipse Treatment Planning System EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Eclipse Treatment Planning System EUDAMED
- Model / Reference
- Eclipse Treatment Planning System 18.0 EUDAMED18.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855141006202 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200107PN EUDAMED
- 510(k) Number
- K230557 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- EMDN Code
- Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMED
- GMDN Term
- Radiation therapy software 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
Eclipse Treatment Planning System 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 | 089947500200107PN | 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 9dd42cc9-a81d-4fe6-b212-2ae79d89060d 61 fields · synced Jul 10, 2026
- FDA UDI 6df5f7d6-f032-456a-a2f3-60d27b92a010 33 fields · synced May 30, 2026