FDA-Device2019-07-10Class II
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
RAYSEARCH LABORATORIES AB
Hazard
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
Sold states
US Nationwide Distribution
Affected count
744
Manufactured in
Sveavagen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1930-2019Don't want to check this manually?
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