FDA-Device2018-06-06Class II
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
NordicNeuroLab AS
Hazard
An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeling, and thus and indirect left-right, up-down or anterior-posterior flipping of images.
Sold states
Worldwide Distribution -- USA, Australia, Denmark, China, France, Japan, Malaysia, Netherlands, USA, Poland, Sweden, Spain, Russia, India, Norway, Singapore, South Korea, United Kingdom, and Slovenia.
Affected count
97 licenses
Manufactured in
Mollendalsveien 65c, N/A, Bergen, N/A, Norway
Products
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2044-2018Don't want to check this manually?
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