# K201607: Eclipse Treatment Planning System v16.1

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 10, 2020 after 25 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K010975 (2001). 20 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200608: Eclipse Treatment Planning System v16.0, Varian Medical Systems, Inc. (2020) Summary page 4.

## Most influential descendants
- K230557: Eclipse Treatment Planning System (v18.0) (2023), 3 descendants of its own
- K242378: Eclipse Treatment Planning System (18.1) (2024), 1 descendant of its own
- K260750: Virtual Cone (1.0) (2026), 0 descendants of its own
- K250963: PlanOne 1 (2025), 0 descendants of its own

## Indications for use
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.

Source page: https://510kreport.com/device/K201607
Methodology: https://510kreport.com/methodology