# K173838: ARIA Radiation Therapy Management

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jan 17, 2018 after 30 days
- Product code: IYE (Accelerator, Linear, Medical)
- 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: 4 generations back to K952313 (1995). 5 ancestors in all.
18 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133572: Aria Radiation Therapy Management, Varian Medical Systems, Inc. (2014) Summary page 4.

## Most influential descendants
- K192377: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon (2020), 9 descendants of its own
- K212294: Ethos Treatment Management, Ethos Treatment Planning (2021), 4 descendants of its own
- K222941: Halcyon, Ethos Radiotherapy System (2023), 3 descendants of its own
- K221408: ARIA Radiation Therapy Management (v16.1 MR3) (2022), 3 descendants of its own
- K232479: ART-Plan (2023), 2 descendants of its own

## Recalls of this device
- Mar 21, 2022 · Class II · Z-0942-2022: Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

## 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.

Source page: https://510kreport.com/device/K173838
Methodology: https://510kreport.com/methodology
