# K162393: The ViewRay (MRIdian) Linac System

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: Feb 24, 2017 after 182 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: 8 generations back to K010975 (2001). 39 ancestors in all.
8 later devices descend from it; 2 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)
- K111862: Viewray System, Viewray, Incorporated (2012) Summary page 4.
- K102915: Viewray Treatment Planning and Delivery System, Viewray, Incorporated (2011) Summary page 4.

## Most influential descendants
- K170751: MRIdian Linac System with 138-leaf Collimator (2017), 7 descendants of its own
- 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

## Indications for use
The ViewRay (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/K162393
Methodology: https://510kreport.com/methodology