BEUDAMED
    6 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: Norway × Clear all

    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 13, 2018

    GE Healthcare Vivid S60, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023

    GE Healthcare Vivid S70, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023

    GE Healthcare Vivid S70N, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023

    GE Healthcare Vivid S60N, ultrasound device

    FDA Enforcement
    Class II ·Ongoing·GE Vingmed Ultrasound As·July 19, 2023

    nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

    FDA Enforcement
    Class II ·Terminated·NordicNeuroLab AS·June 6, 2018