# K212958: MRIdian Linac System

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: Dec 14, 2021 after 89 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: 11 generations back to K010975 (2001). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181989: MRIdian Linac System, Viewray, Incorporated (2019) Summary page 5.

## Indications for use
The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Source page: https://510kreport.com/device/K212958
Methodology: https://510kreport.com/methodology