# K111862: Viewray System

- Pathway: 510(k) (Traditional)
- Applicant: Viewray, Incorporated
- Decided: May 22, 2012 after 327 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K926449 (1995). 26 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092871: Trilogy MX, Varian Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K162393: The ViewRay (MRIdian) Linac System (2017), 8 descendants of its own
- 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

## Recalls of this device
- Oct 20, 2020 · Class II · Z-0481-2021: 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 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
- Mar 7, 2016 · Class II · Z-1309-2016: When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the n
- Dec 24, 2015 · Class II · Z-0806-2016: The system loaded a completion fraction in the incorrect order after a treatment interruption.
- Aug 27, 2015 · Class II · Z-0115-2016: ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.
- May 7, 2015 · Class II · Z-1954-2015: The software was failing to determine new patient locations if imaging is not enabled during treatment.
- Apr 1, 2015 · Class II · Z-2085-2015: ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
- Jan 15, 2015 · Class II · Z-1580-2015: The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch

## Indications for use
The ViewRay 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/K111862
Methodology: https://510kreport.com/methodology