# K222728: Radiation Planning Assistant (RPA)

- Pathway: 510(k) (Traditional)
- Applicant: University of Texas, MD Anderson Cancer Center
- Decided: May 17, 2023 after 251 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K242822: ART-Plan+ (v.3.0.0) (2025), 1 descendant of its own
- K253091: ART-Plan+ (v3.1.0) (2025), 0 descendants of its own

## Indications for use
The Radiation Planning Assistant (RPA) is used to plan radiotherapy treatments for patients with cancers of the head and neck, cervix, breast, and metastases to the brain. The RPA is used to plan external beam irradiation with photon beams using CT images. The RPA is used to create contours and treatment plans that the user imports into their own Treatment Planning System (TPS) for review, editing, and re-calculation of the dose. Some functions of the RPA use Eclipse 15.6. The RPA is not intended to be used as a primary treatment planning system. All automatically generated contours and plans must be imported into the user's own treatment planning system for review, edit, and final dose calculation.

Source page: https://510kreport.com/device/K222728
Methodology: https://510kreport.com/methodology