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VIEWRAY INCORPORATED

Last updated May 23, 2026

Information

Device	Model / Reference	Registries	Class	Status
Head Neck Coil (Receive Only) – Bottom	11765	FDA UDI	Class II	Active
MRIdian Linac System	20000-01	FDA UDI	Class II	Active
MRIdian LINAC	20000	FDA UDI	Class II	Active
Head Coil (Receive Only)	23820	FDA UDI	Class II	Active
MRIdian A3i Software	A3i	FDA UDI	Class II	Active
Head Neck Coil (Receive Only) – Top	14775	FDA UDI	Class II	Active
Medium Torso Coil (Receive Only) – Bottom	12981	FDA UDI	Class II	Active
Medium Torso Coil (Receive Only) – Top	14774	FDA UDI	Class II	Active
MRIdian Linac System	K181989	FDA 510(k)	Class II	Active
The ViewRay (MRIdian) Linac System	K162393	FDA 510(k)	Class II	Active
MRIdian Linac System	K212958	FDA 510(k)	Class II	Active
Viewray System	K111862	FDA 510(k)	Class II	Active
Viewray Treatment Planning And Delivery System	K102915	FDA 510(k)	Class II	Active
MRIdian Linac System with 138-leaf Collimator	K170751	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 7, 2016	Z-1309-2016	—	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.
Dec 24, 2015	Z-0806-2016	—	terminated	The system loaded a completion fraction in the incorrect order after a treatment interruption.
Aug 27, 2015	Z-0115-2016	—	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.
May 7, 2015	Z-1954-2015	—	terminated	The software was failing to determine new patient locations if imaging is not enabled during treatment.
Apr 1, 2015	Z-2085-2015	—	terminated	ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
Jan 15, 2015	Z-1580-2015	—	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.