# K221448: ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 15, 2022 after 28 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). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 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.

## Indications for use
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. 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/K221448
Methodology: https://510kreport.com/methodology