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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 31 Results
510(K) Number: K190387
 
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Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Num... 2 02/19/2025 RAYSEARCH LABORATORIES AB
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System. 2 05/01/2024 RAYSEARCH LABORATORIES AB
RayStation 8.1.0.47, 8.1.1.8 and 8.1.2.5. Radiation Therapy Treatment Planning System. 2 05/01/2024 RAYSEARCH LABORATORIES AB
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B,... 2 04/05/2024 RAYSEARCH LABORATORIES AB
Raystation treatment planning system for radiation therapy, Model Numbers 9.0.0, 9.0.1, 9.1.0, 9.2.0... 2 03/22/2023 RAYSEARCH LABORATORIES AB
RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including a... 2 06/24/2020 RAYSEARCH LABORATORIES AB
RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology whic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology whic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation... 2 06/10/2020 RAYSEARCH LABORATORIES AB
RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medic... 2 06/10/2020 RAYSEARCH LABORATORIES AB
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