Eclipse Treatment Planning System 17.0
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
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 17.0 EUDAMED17.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855141006103 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200107PN EUDAMED
- 510(k) Number
- K201607 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
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Eclipse Treatment Planning System is a 3-dimensional radiotherapy treatment planning system designed to support photon, proton, electron, and brachytherapy modalities. It enables accurate dose calculation to assist clinicians in planning radiation therapy for patients with malignant or benign diseases.
This system is developed by Varian Medical Systems, Inc. and is authorized under FDA 510(k) and MDR regulations. It is a non-sterile, non-implantable software-based device intended for use in clinical radiation therapy environments.
Frequently asked questions
What is the Eclipse Treatment Planning System used for?
The system is used to plan radiotherapy treatments for patients diagnosed with malignant or benign diseases by enabling accurate dose calculations for various radiation modalities.
Is the Eclipse Treatment Planning System sterile?
No, the device is not sterile. As a software-based treatment planning system, it does not require sterilization for its intended use in a clinical setting.
Who is the manufacturer of the Eclipse Treatment Planning System?
The device is manufactured by Varian Medical Systems, Inc., based in Palo Alto, California.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cancer Care - Eclipse | Siemens Healthineers, External beam planning module of Eclipse ... - ScienceDirect.com, External beam planning module of Eclipse for ... - PubMed, [PDF] Varian Medical Systems, Inc. May 26, 2023 Peter Coronado Sr ..., [PDF] Elevate your treatment planning with Eclipse
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K073020 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K050296 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K181145 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K172163 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K102011 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K133247 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K170969 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K131891 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K141283 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K030981 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K152393 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200107PN | 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 08eaf20f-4588-4731-a95d-c86dac566441 85 fields · synced Oct 6, 2026
- FDA UDI 532d52bf-f759-468e-b3c8-b3790a2df12f 33 fields · synced May 30, 2026
- FDA 510(k) K073020 1 fields · synced May 18, 2026