# K170969: Eclipse Treatment Planning System

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jul 5, 2017 after 96 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: 12 generations back to K010975 (2001). 16 ancestors in all.
30 later devices descend from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152393: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2015) Summary page 4.

## Most influential descendants
- 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
- K200608: Eclipse Treatment Planning System v16.0 (2020), 5 descendants of its own

## Recalls of this device
- Dec 26, 2018 · Class II · Z-0771-2019: There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range in

## 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/K170969
Methodology: https://510kreport.com/methodology