8 results
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31ms
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Sources: EU EUDAMED, US FDA
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nordicTumorEx 1.0 nordicTumorEx 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·December 15, 2014
fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone.
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LNH·October 28, 2017
nordicBrainEX, software versions 2.21 through 2.3.10
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·June 16, 2022
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·September 12, 2014
nordicICE v 2.3.14 nordicICE 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. nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·July 3, 2015
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 Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·December 21, 2012
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 Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LLZ·September 17, 2014
fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1
FDA Recall
Terminated
·NordicNeuroLab AS Mollendalsveien 65c Bergen Norway·Product code LNH·August 20, 2018