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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K200569
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RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.... 2 11/20/2020 RAYSEARCH LABORATORIES AB
RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all... 2 12/15/2020 RAYSEARCH LABORATORIES AB
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.115... 2 04/15/2021 RAYSEARCH LABORATORIES AB
RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9... 2 05/14/2021 RAYSEARCH LABORATORIES AB
RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 10A, 10B i... 2 05/14/2021 RAYSEARCH LABORATORIES AB
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 ,... 2 06/09/2021 RAYSEARCH LABORATORIES AB
RayStation (Radiation Treatment Planning System) : RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B an... 2 07/23/2021 RAYSEARCH LABORATORIES AB
RayStation 9B SP1. For radiation treatment planning. 2 07/19/2022 RAYSEARCH LABORATORIES AB
Radiation therapy software, RayStation standalone software treatment planning system. Model numbers:... 2 06/29/2023 RaySearch America Inc
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B,... 2 04/05/2024 RAYSEARCH LABORATORIES AB
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