BEUDAMED
    24 results · 19ms · 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 ×

    ISO FILE, GENIE MEDICAL BAHS 2023.1 UK

    Device
    EU MDR · Eu Md Class 2a ·Oticon Medical AB·On the market·15 countries

    ISO FILE, GENIE MEDICAL BAHS 2024.2 UK

    Device
    EU MDR · Eu Md Class 2a ·Oticon Medical AB·On the market·15 countries

    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 (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·June 16, 2021

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·April 1, 2015

    RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 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, 9.1, 9.2, 10.0)

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·December 23, 2020