Viewray Incorporated
United StatesFDA applicant, unverified
Viewray Incorporated is a medical device manufacturer, with 14 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) and 6 FDA recalls as of 12 Nov 2026.
- Devices
- 14
- FDA recalls
- 6
Registry facts
- Registries
- FDA GUDID 8
- FDA 510(k) 6
- Device classes
- FDA Class II 14
- FDA recalls
- Identifiers
- DUNS 015705677
At a glance
Market reach
- United States
- FDA recalls
What Viewray Incorporated makes
ViewRay Incorporated makes magnetic resonance imaging-guided radiation therapy systems, specifically the MRIdian Linac System and related components such as receive-only head, neck, and torso coils used for patient positioning and imaging during treatment.
Catalogue
Search and filter all 14 devicesCompany details
- DUNS number
- 015705677
FDA recalls
FDA recall records list 6 recalls initiated by VIEWRAY INCORPORATED, the earliest on 2015-01-15 and the most recent on 2016-03-07. By recorded status: 6 terminated. The reasons filed fall into these groups: software or firmware and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 7 Mar 2016 Z-1309-2016 Class II Terminated 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.
Full distribution text
- 7 Mar 2016 Z-1309-2016 Class II Terminated 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.
2015
- 24 Dec 2015 Z-0806-2016 Class II Terminated The system loaded a completion fraction in the incorrect order after a treatment interruption.
- 27 Aug 2015 Z-0115-2016 Class II Terminated 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.
- 7 May 2015 Z-1954-2015 Class II Terminated The software was failing to determine new patient locations if imaging is not enabled during treatment.
- 1 Apr 2015 Z-2085-2015 Class II Terminated ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
- 15 Jan 2015 Z-1580-2015 Class II Terminated 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.
Frequently asked questions
How many devices does VIEWRAY INCORPORATED have in the registry?
The registry currently lists 14 devices for VIEWRAY INCORPORATED. Devices recorded under merged duplicate company entries are counted once.
Which registries list VIEWRAY INCORPORATED's devices?
Among its 14 most recently registered devices, VIEWRAY INCORPORATED has devices listed in FDA 510(k) (6 devices) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do VIEWRAY INCORPORATED's devices fall under?
Among its 14 most recently registered devices, the classes recorded for VIEWRAY INCORPORATED's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for VIEWRAY INCORPORATED?
FDA recall records list 6 recalls initiated by VIEWRAY INCORPORATED, the most recent initiated on 7 Mar 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from VIEWRAY INCORPORATED in the registry?
The most recently registered devices listed for VIEWRAY INCORPORATED include Head Neck Coil (Receive Only) – Bottom 11765, MRIdian Linac System 20000-01, MRIdian LINAC 20000 and Head Coil (Receive Only) 23820.