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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Sweden ×

    RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8A, UDI # 07350002010112 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 17, 2020

    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 25, 2014

    Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.

    FDA Enforcement
    Class II ·Terminated·Permobil, Ab·September 26, 2018

    Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 19, 2017

    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 including some of the Service Packs. Standalone software treatment planning system

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·May 26, 2021

    RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·January 1, 2020