FDA-Device2026-01-28Class II
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
RAYSEARCH LABORATORIES AB
Hazard
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Sold states
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Affected count
119
Manufactured in
Eugeniavagen 18c, Stockholm, Sweden
Products
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1106-2026Don't want to check this manually?
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