# K181989: MRIdian Linac System

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: Feb 20, 2019 after 209 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 2 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 43 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.
- K162393: The ViewRay (MRIdian) Linac System, Viewray, Incorporated (2017) Summary page 4.

## Most influential descendants
- K212958: MRIdian Linac System (2021), 0 descendants of its own

## Recalls of this device
- May 4, 2021 · Class II · Z-1836-2021: Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
- Oct 20, 2020 · Class II · Z-0482-2021: There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.

## 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/K181989
Methodology: https://510kreport.com/methodology