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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 7 of 7 Results
510(K) Number: K180379
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Product Description
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Recall
Class
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FDA Recall
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RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19.... 2 09/02/2025 RAYSEARCH LABORATORIES AB
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog N... 2 02/19/2025 RAYSEARCH LABORATORIES AB
RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System. 2 05/01/2024 RAYSEARCH LABORATORIES AB
RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStati... 2 07/05/2019 RAYSEARCH LABORATORIES AB
RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software... 2 10/30/2018 RAYSEARCH LABORATORIES AB
RayStation Radiation Therapy Treatment Planning System, Model nos. 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9... 2 07/26/2018 RAYSEARCH LABORATORIES AB
RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStati... 2 07/19/2018 RAYSEARCH LABORATORIES AB
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