8 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
FDA Enforcement
Class II
·Terminated·Viewray Incorporated·February 24, 2016
MRIdian Linac Radiation Therapy System, Model 20000.
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·May 8, 2019
ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·May 6, 2020
MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·December 18, 2019
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 Enforcement
Class II
·Terminated·Viewray, Inc.·December 2, 2020
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 Enforcement
Class II
·Terminated·Viewray, Inc.·December 2, 2020
ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.
FDA Enforcement
Class II
·Terminated·Viewray, Inc.·June 16, 2021
Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Viewray Incorporated·July 8, 2015