Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NorwayLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list NordicNeuroLab with 13 510(k) clearances, 8 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Mar 20, 2026: nordicAudio (1.0).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 20, 2026 | nordicAudio (1.0)K251937 · LNH | 510(k) clearances |
| Oct 22, 2024 | nordicMEDiVAK243209 · LLZ | 510(k) clearances |
| Oct 22, 2024 | nordicMEDiVAK243209 · Radiology | AI-enabled devices |
| Jun 28, 2024 | nordicMEDiVAK241608 · LLZ | 510(k) clearances |
| Dec 13, 2023 | fMRI Hardware SystemK232680 · LNH | 510(k) clearances |
| Jun 16, 2022 | nordicBrainEX, software versions 2.21 through 2.3.10Class II · When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay | Device recalls |
| Mar 3, 2022 | nordicDSCK212720 · LLZ | 510(k) clearances |
| Nov 27, 2019 | fMRI Hardware SystemK191032 · LNH | 510(k) clearances |
| Aug 20, 2018 | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented Class II · Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner). | Device recalls |
| Oct 28, 2017 | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scClass II · Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphon | Device recalls |
| Jan 27, 2017 | nordicBrainExK163324 · LLZ | 510(k) clearances |
| Jul 3, 2015 | nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to phyClass II · The bug causes BOLD activation maps to be visualized as overlays without taking the coregistration into account. Any ou | Device recalls |
| Dec 15, 2014 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited tClass II · An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeli | Device recalls |
| Sep 17, 2014 | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and pClass II · An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeli | Device recalls |
| Sep 12, 2014 | nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.Class II · An error was discovered in the interpretation of certain DICOM header tags that may lead to incorrect orientation labeli | Device recalls |
| Aug 7, 2014 | LCD MONITORK140956 · LNH | 510(k) clearances |
| Dec 21, 2012 | nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but notClass II · There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
