FDA-Device2018-11-07Class II
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
RAYSEARCH LABORATORIES AB
Hazard
Robust optimization for plans using beam set + background dose is not supported in RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7.
Sold states
Nationwide
Affected count
110 units
Manufactured in
Sveavagen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2019Don't want to check this manually?
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