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Eclipse Treatment Planning System 15.6
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Eclipse Treatment Planning System 15.6
Identity
- Trade Name
- Eclipse Treatment Planning System 15.6 EUDAMEDEclipse Treatment Planning System for External Beam Radiation Therapy FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Eclipse Treatment Planning System EUDAMED
- Model / Reference
- Eclipse Treatment Planning System 15.6 EUDAMED15.6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855141006066 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855141006066 EUDAMED
- 510(k) Number
- K181145 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- EMDN Code
- Z11010482 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - SOFTWARE ACCESSORIES 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
- -1192 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Eclipse Treatment Planning System 15.6 by Varian Medical Systems, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855141006066 | 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 1ef93eba-a891-4259-be9f-29067ae8e344 61 fields · synced Jun 18, 2026
- FDA UDI b129692c-9271-47ab-9ee8-ff036eceb92d 33 fields · synced May 30, 2026