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Eclipse Treatment Planning System v16.0

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200608

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K200608 FDA 510(k)
FDA Product Code
MUJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Eclipse Treatment Planning System v16.0 is a Radiation Therapy Treatment Planning System, designed to calculate and optimize radiation dose distributions for cancer treatment. It integrates with imaging data to generate precise treatment plans for external beam radiotherapy, ensuring accurate delivery of therapeutic doses to targeted tissues while minimizing exposure to healthy areas.

This software-based system is intended for use in radiation oncology departments, typically within hospital or clinic settings. It operates on Windows, macOS, and Linux platforms and is supplied as a standalone application requiring installation and periodic updates. The system holds FDA 510(k) clearance and MDR compliance, adhering to regulatory standards for radiation therapy planning devices. No physical sterility or single-use considerations apply, as it is a reusable digital solution.

Frequently asked questions

What operating systems is the Eclipse Treatment Planning System v16.0 compatible with and how is it delivered?

The Eclipse Treatment Planning System v16.0 is designed to run on Windows, macOS, and Linux platforms. It is supplied as a standalone software application that requires installation on a compatible system. Updates are provided periodically to ensure the system remains current with the latest features and regulatory standards.

Is the Eclipse Treatment Planning System v16.0 intended for single-use or reusable applications, and does it have sterility considerations?

The Eclipse Treatment Planning System v16.0 is a reusable digital solution and does not have physical sterility considerations, as it is a software-based tool. Since it operates within radiation oncology departments, it is meant for repeated use across multiple treatment planning sessions.

What regulatory pathways has the Eclipse Treatment Planning System v16.0 followed, and what does this mean for its use in clinical settings?

The Eclipse Treatment Planning System v16.0 holds FDA 510(k) clearance and is compliant with the EU Medical Device Regulation (MDR). This means it has undergone regulatory review to demonstrate substantial equivalence to a previously cleared device and meets EU safety and performance standards, ensuring its suitability for use in radiation therapy planning within clinical settings.

How does the Eclipse Treatment Planning System v16.0 integrate with other systems in a radiation oncology workflow?

The Eclipse Treatment Planning System v16.0 integrates with imaging data to generate precise radiation dose distributions for external beam radiotherapy. This integration allows clinicians to create optimized treatment plans that deliver therapeutic doses to targeted cancerous tissues while minimizing exposure to surrounding healthy tissues, enhancing the accuracy and effectiveness of radiation therapy.

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: Download Eclipse IDE (free) for Windows, macOS and Linux | Gizmodo

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Varian Medical Systems, Inc.

Sources (2)

  • FDA 510(k) K200608 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026