# K192377: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon

- Pathway: 510(k) (Traditional)
- Applicant: Varian Medical Systems, Inc.
- Decided: Feb 10, 2020 after 164 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 15 generations back to K010975 (2001). 61 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173838: ARIA Radiation Therapy Management, Varian Medical Systems, Inc. (2018) Summary page 4.
- K181145: Eclipse Treatment Planning System, Varian Medical Systems, Inc. (2018) Summary page 4.
- K181032: Halcyon, Varian Medical Systems, Inc. (2018) Summary page 4.

## Most influential descendants
- K212294: Ethos Treatment Management, Ethos Treatment Planning (2021), 4 descendants of its own
- K222941: Halcyon, Ethos Radiotherapy System (2023), 3 descendants of its own
- K232479: ART-Plan (2023), 2 descendants of its own
- K232113: Halcyon, Ethos Radiotherapy System (2023), 2 descendants of its own
- K252977: Halcyon, Ethos Radiotherapy System (5.0) (2026), 1 descendant of its own

## Indications for use
Ethos Treatment Management is indicated for use in managing and monitoring radiation therapy treatment plans and sessions. Ethos Treatment Planning is indicated for use in generating and modifying radiation therapy treatment plans. Halcyon and Ethos Radiotherapy System are indicated for the delivery of stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated for adults and pediatric patients.

Source page: https://510kreport.com/device/K192377
Methodology: https://510kreport.com/methodology