Viewray System
510(k) K111862
Viewray System is a Class II device made by Viewray Incorporated, cleared under FDA 510(k) K111862 on 22 May 2012, active as of 22 Oct 2026. 9 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK111862 | Date22 May 2012 | StatusActive |
Official records
- FDA 510(k) database K111862
Recalls
-
- Terminated 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.
-
- Terminated 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 structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
-
- Terminated 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 operating system.
-
- Terminated 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 new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.
-
- Terminated Z-0806-2016
The system loaded a completion fraction in the incorrect order after a treatment interruption.
-
- Terminated 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.
-
- Terminated Z-1954-2015
The software was failing to determine new patient locations if imaging is not enabled during treatment.
-
- Terminated Z-2085-2015
ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
-
- Terminated 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 error.
Timeline
- Cleared FDA 510(k) K111862
- Recall initiated FDA recalls Z-1580-2015
- Recall initiated FDA recalls Z-2085-2015
- Recall initiated FDA recalls Z-1954-2015
- Recall initiated FDA recalls Z-0115-2016
- Recall initiated FDA recalls Z-0806-2016
- Recall initiated FDA recalls Z-1309-2016
- Recall initiated FDA recalls Z-0676-2020
- Recall initiated FDA recalls Z-1803-2020
- Recall initiated FDA recalls Z-0481-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Viewray, Incorporated
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- ImagingRing System on Rails by medPhoton GmbH
- TBI Stand by Mick Radio-Nuclear Instruments, Inc.
- KLARITY MEDICAL R550-EM1 by Klarity Medical Products, LLC
- Model 35300 Tracker Therapy Beam Evaluator by Keithley Instruments, Inc.
- Clinac 4/100 by Varian Assoc., Inc.
- KLARITY MEDICAL RNB-100 by Klarity Medical Products, LLC
- Varian Unique Single Energy Linear Accelerator by Varian Medical Systems, Oncology Systems
- TrueBeam, TrueBeam STx, Edge, VitalBeam by Varian Medical Systems, Inc.
- Encompass SRS Headframe ; Encompass MR SRS Headframe by Qfix
- Anchored Beacon transponder, Beacon Care Package - Lung by Varian Medical Systems, Inc.