U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The bug causes bold activation maps to be visualized as overlays without taking the coregistration into account. any output created from these activation maps as overlays will not be adjusted according to the coregistration.
조치
The firm notified their customers by email on July 3, 2015.
Actions to be taken by the customer/User:
We advise users to immediately stop using the BOLD module in nordiclCE and contact NordicNeuroLab for further instructions on how to upgrade the nordiclCE BOLD module, as described more fully below.
For further questions, please call (262) 337-2909.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia , Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Italy, Japan, Kuwait, Malaysia, Netherlands, Norway and Poland.
제품 설명
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.