FDA-Device2020-07-01Class II
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
RAYSEARCH LABORATORIES AB
Hazard
It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
Sold states
Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
Affected count
12
Manufactured in
Sveavagen 9, N/A, Stockholm, N/A, Sweden
Products
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2426-2020Don't want to check this manually?
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