6 results
·
45ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VIEWRAY SYSTEMS, INC.
FDA registration
VIEWRAY SYSTEMS, INC.·2 products·🇺🇸 United States
MRIDIAN A3I SYSTEM
FDA Adverse Event
Injury
·VIEWRAY SYSTEMS INC.·Product code IYE·April 8, 2026
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
FDA Enforcement
Class II
·Terminated·Viewray Incorporated·February 24, 2016
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
FDA Recall
Terminated
·Viewray Incorporated·Product code IYE·December 24, 2015
ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the 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.
FDA Recall
Terminated
·Viewray, Inc.·Product code IYE·October 20, 2020
ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the 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.
FDA Recall
Terminated
·Viewray, Inc.·Product code IYE·October 20, 2020