Eclipse Treatment Planning System (v18.0)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Eclipse Treatment Planning System EUDAMEDFDA UDIEclipse 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 18.1 EUDAMEDEclipse Treatment Planning System 16.1 EUDAMED18.1 FDA UDI16.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855141006349 EUDAMEDFDA UDI00855141006080 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200107PN EUDAMED
- FDA Product Code
- MUJ FDA 510(k)FDA UDI
- EMDN Code
- Z11010401 RADIOTHERAPY TREATMENT PLANNING SYSTEMS EUDAMEDZ11010482 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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 (v18.0) is a computer-based software system classified as a Radiation Therapy Treatment Planning System. It is designed to assist radiation oncologists and physicists in creating precise, individualized radiation treatment plans for cancer patients by simulating dose distributions and optimizing therapy parameters.
This system is supplied as a software license for installation on compatible hardware within radiation oncology departments. It operates in non-sterile environments and is intended for single-user, multi-session use in clinical settings. The system has received FDA 510(k) clearance and is compliant with the EU Medical Device Regulation (MDR). No specific MRI safety classification or sterility requirements are noted in the provided data.
Frequently asked questions
What is the Eclipse Treatment Planning System (v18.0) used for in a clinical setting?
The Eclipse Treatment Planning System (v18.0) is designed to assist radiation oncologists and physicists in creating precise, individualized radiation treatment plans for cancer patients. It simulates dose distributions and optimizes therapy parameters to help ensure accurate and effective radiation therapy delivery.
How is the Eclipse Treatment Planning System supplied and where is it used?
The Eclipse Treatment Planning System is supplied as a software license for installation on compatible hardware within radiation oncology departments. It operates in non-sterile environments and is intended for single-user, multi-session use in clinical settings, meaning it is not meant for sterile procedures or shared use outside of authorized installations.
Is the Eclipse Treatment Planning System reusable or single-use, and what are its regulatory approvals?
The Eclipse Treatment Planning System is intended for single-user, multi-session use, meaning it is not a single-use device but rather a reusable software solution within its designated clinical environment. It has received FDA 510(k) clearance and is compliant with the EU Medical Device Regulation (MDR), ensuring it meets regulatory standards for use in both U.S. and EU markets.
What type of hardware compatibility does the Eclipse Treatment Planning System require for installation?
The Eclipse Treatment Planning System requires installation on compatible hardware within radiation oncology departments, though the specific hardware requirements are not detailed in the provided data. It is a software-based system and does not include physical hardware components, so the clinical environment must meet the manufacturer’s technical specifications for proper operation.
How does the Eclipse Treatment Planning System relate to MRI safety, and what are its regulatory routes?
The Eclipse Treatment Planning System is not classified under MRI safety protocols, as it operates in non-sterile, non-imaging environments for radiation therapy planning. Its regulatory route includes FDA 510(k) clearance and compliance with the EU Medical Device Regulation (MDR), confirming its suitability for use in radiation oncology settings under these frameworks.
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: Eclipse | Siemens Healthineers | Cancer Care - Varian, Treatment planning software - Eclipse™ - Varian Oncology - medical ..., Eclipse Treatment Planning System (v18.0) (K230557) — FDA 510 (k ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230557 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (5)
- FDA 510(k) K230557 24 fields · synced Oct 6, 2026
- FDA UDI 3e73f954-917f-4db2-8c92-70be8a22aa44 33 fields · synced May 29, 2026
- FDA UDI 84022bd5-aff8-49a2-b338-b24dae0d6151 33 fields · synced May 29, 2026
- EUDAMED d2d29907-c637-4ed5-8177-d6c468ac735a 61 fields · synced Jul 21, 2026
- EUDAMED 1e93b6ca-2702-4f33-bfeb-ba038b4b928c 61 fields · synced Jul 24, 2026