BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    SRX Ice Wrap

    Device
    EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·On the market

    Let's Sing Ice Blue

    Device
    EU MDR · Eu Md Class 1 ·Trust Care AB·On the market

    Let's Frisbee Ice Blue

    Device
    EU MDR · Eu Md Class 1 ·Trust Care AB·On the market

    Let's Shower Ice Blue

    Device
    EU MDR · Eu Md Class 1 ·Trust Care AB·On the market

    Let's Enjoy Ice Blue

    Device
    EU MDR · Eu Md Class 1 ·Trust Care AB·On the market

    SRX Ice Wrap

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Mediroyal Nordic AB·1 device

    RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·September 2, 2015

    RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Software Version: 11.0.4.15. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0.1.52. 5. RayStation 10A Service Pack 2, Software Version: 10.0.2.10. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Software Version: 12.0.4.12. 5. RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025