# K170751: MRIdian Linac System with 138-leaf Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: Jun 7, 2017 after 86 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K010975 (2001). 40 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162393: The ViewRay (MRIdian) Linac System, Viewray, Incorporated (2017) Summary page 4.

## Most influential descendants
- K182076: Elekta Unity (2018), 3 descendants of its own
- K192482: Elekta Unity (2019), 2 descendants of its own
- K212114: Elekta Unity (2021), 1 descendant of its own
- K181989: MRIdian Linac System (2019), 1 descendant of its own
- K223209: Elekta Unity (2023), 0 descendants of its own

## Recalls of this device
- 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.
- Nov 18, 2019 · Class II · Z-1803-2020: Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structu
- Mar 18, 2019 · Class II · Z-1251-2019: A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
- Mar 3, 2019 · Class II · Z-0676-2020: Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software ope

## 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/K170751
Methodology: https://510kreport.com/methodology