# K213526: Aurora-RT

- Pathway: 510(k) (Traditional)
- Applicant: Magnettx Oncology Solutions, Ltd.
- Decided: May 4, 2022 after 181 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: 10 generations back to K010975 (2001). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170751: MRIdian Linac System with 138-leaf Collimator, Viewray, Incorporated (2017) Summary page 4.

## Indications for use
The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K213526
Methodology: https://510kreport.com/methodology