FDA-Device2019-05-08Class II
MRIdian Linac Radiation Therapy System, Model 20000.
Viewray, Inc.
Hazard
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Sold states
Distribution was made to FL, IL, MI, MO, NY, and WI. There was no government/military distribution. Foreign distribution was made to Denmark, France, Germany, Netherlands, South Korea, Switzerland, Turkey, UAE,
Affected count
17 devices
Manufactured in
815 E Middlefield Rd, N/A, Mountain View, CA, United States
Products
MRIdian Linac Radiation Therapy System, Model 20000.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1251-2019Don't want to check this manually?
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