FDA-Device2015-05-13Class II
ViewRay System, Radiation Therapy System
Viewray Incorporated
Hazard
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.
Sold states
US distribution to MO.
Affected count
1
Manufactured in
2 Thermo Fisher Way, N/A, Oakwood Village, OH, United States
Products
ViewRay System, Radiation Therapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1580-2015Don't want to check this manually?
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