NordicNeuroLab AS
FDA Regulatory Profile
NordicNeuroLab AS appears in FDA public data with 8 recalls, 13 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1462-2022, Class II) was initiated on June 16, 2022. Its most recent 510(k) clearance was granted on March 20, 2026.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 13
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1462-2022 | Class II | nordicBrainEX, software versions 2.21 through 2.3.10 | June 16, 2022 |
| Z-3023-2018 | Class II | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter | August 20, 2018 |
| Z-2103-2018 | Class II | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the | October 28, 2017 |
| Z-2061-2018 | Class II | nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained profes | July 3, 2015 |
| Z-2042-2018 | Class II | nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained p | December 15, 2014 |
| Z-2050-2018 | Class II | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, | September 17, 2014 |
| Z-2044-2018 | Class II | nordicICE 2.3.14 Image processing software package used by trained professionals, including phys | September 12, 2014 |
| Z-2045-2018 | Class II | nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by | December 21, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251937 | nordicAudio (1.0) | March 20, 2026 |
| K243209 | nordicMEDiVA | October 22, 2024 |
| K241608 | nordicMEDiVA | June 28, 2024 |
| K232680 | fMRI Hardware System | December 13, 2023 |
| K212720 | nordicDSC | March 3, 2022 |
| K191032 | fMRI Hardware System | November 27, 2019 |
| K163324 | nordicBrainEx | January 27, 2017 |
| K140956 | LCD MONITOR | August 7, 2014 |
| K133910 | NORDICBRAINEX | April 4, 2014 |
| K123306 | NORDIC TUMOREX | May 20, 2013 |
| K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM | October 8, 2009 |
| K080515 | FMRI HARDWARE SYSTEM | May 16, 2008 |
| K073099 | FMRI HARDWARE SYSTEM | November 20, 2007 |