# K152393: Eclipse Treatment Planning System

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Sep 18, 2015 after 25 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010975 (2001). 15 ancestors in all.
33 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141283: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2014) Summary page 4.

## Most influential descendants
- K170969: Eclipse Treatment Planning System (2017), 30 descendants of its own
- K172163: Eclipse Treatment Planning System (2017), 29 descendants of its own
- K181145: Eclipse Treatment Planning System (2018), 26 descendants of its own
- K192377: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (2020), 9 descendants of its own
- K210645: RayStation 10.1 (2021), 5 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0805-2016: When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calcu

## 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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Source page: https://510kreport.com/device/K152393
Methodology: https://510kreport.com/methodology