BEUDAMED
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    RayStation Product Usage: 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.

    FDA Enforcement
    Class II ·Terminated·RAYSEARCH LABORATORIES AB·January 24, 2018

    RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System 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·December 14, 2016

    CARBON DIOXIDE (MEDICAL DEVICE) 2.5L

    Device
    EU MDD · Eu Md Class 2a ·Linde Sverige AB (Linde Gas)·On the market·8 countries

    Healing Cap

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·Oticon Medical AB·2 devices

    CARBON DIOXIDE (MEDICAL DEVICE) 2.5L

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·Linde Sverige AB (Linde Gas)·1 device

    DD 2349717-1

    Certificate
    MDD Annex V·Linde Sverige AB (Linde Gas)·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI