NordicNeuroLab AS

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
12
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1462-2022Class IInordicBrainEX, software versions 2.21 through 2.3.10June 16, 2022
Z-3023-2018Class IIfMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter August 20, 2018
Z-2103-2018Class IIfMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the October 28, 2017
Z-2061-2018Class IInordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained profesJuly 3, 2015
Z-2042-2018Class IInordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained pDecember 15, 2014
Z-2050-2018Class IInordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain,September 17, 2014
Z-2044-2018Class IInordicICE 2.3.14 Image processing software package used by trained professionals, including physSeptember 12, 2014
Z-2045-2018Class IInordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used byDecember 21, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K243209nordicMEDiVAOctober 22, 2024
K241608nordicMEDiVAJune 28, 2024
K232680fMRI Hardware SystemDecember 13, 2023
K212720nordicDSCMarch 3, 2022
K191032fMRI Hardware SystemNovember 27, 2019
K163324nordicBrainExJanuary 27, 2017
K140956LCD MONITORAugust 7, 2014
K133910NORDICBRAINEXApril 4, 2014
K123306NORDIC TUMOREXMay 20, 2013
K092253MODIFICATION TO FMRI HARDWARE SYSTEMOctober 8, 2009
K080515FMRI HARDWARE SYSTEMMay 16, 2008
K073099FMRI HARDWARE SYSTEMNovember 20, 2007