BEUDAMED
    12 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Ongoing × Clear all

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.0.0.24 Software Version: RayStation 6

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 5.0.2.35 and 5.0.3.17 Software Version: RayStation 5 Service Pack 2 and 3

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4 and 4.7.6.7 Software Version: RayStation 4.5.1, 4.7.2, 4.7.3, 4.7.4, 4.7.5 and 4.7.6

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: RayStation 10B and 10B Service Pack 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version: RayStation 6 Service Pack 1, 2 and 3

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Version: RayStation 7, 8A and 8A Service Pack 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0.1.29, 11.0.3.116 and 11.0.4.15 Software Revisions: RayStation 11A and 11A Service Pack 1, 2 and 3

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52 and 10.0.2.10 Software Version: RayStation 9B, 9B Service Pack 1, 10A, 10A Service Pack 1 and 2

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119 Software Version: RayStation 11B and 11B Service Pack 1, 2, 3 and Service Pack Toshiba 1

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·February 26, 2025

    GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·October 2, 2024