FDA-Device2021-06-16Class II
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.
Viewray, Inc.
Hazard
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
Sold states
International distribution only to the countries of France, Germany, Italy, and Switzerland.
Affected count
8 versions
Manufactured in
815 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2021Don't want to check this manually?
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