15 results
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27ms
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Sources: EU EUDAMED, US FDA
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Country: Norway
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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
Dignio AS
Authorized representative
🇳🇴 Norway·1 Manufacturer·1 Device
Vingmed AS
Importer
🇳🇴 Norway·16 Manufacturers
Inter-Medical AS
Importer
🇳🇴 Norway·1 Manufacturer
GE Healthcare AS
Importer
🇳🇴 Norway·1 Manufacturer
Starkey Norway AS
Importer
🇳🇴 Norway·1 Manufacturer
Norengros Kjosavik AS
Importer
🇳🇴 Norway·2 Manufacturers
Skope Medical Norway AS
Importer
🇳🇴 Norway·4 Manufacturers
Technomedics Norge AS
Importer
🇳🇴 Norway·12 Manufacturers
Triolab AS
Importer
🇳🇴 Norway·5 Manufacturers