NordicNeuroLab AS
BERGEN Hordaland, NO
NORDICNEUROLAB AS appears in FDA device records in BERGEN Hordaland, NO. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for NordicNeuroLab AS between 2007 and 2026. The busiest year on record is 2014, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251937 | nordicAudio (1.0) | LNH | Substantially Equivalent | |
| K243209 | nordicMEDiVA | LLZ | Substantially Equivalent | |
| K241608 | nordicMEDiVA | LLZ | Substantially Equivalent | |
| K232680 | fMRI Hardware System | LNH | Substantially Equivalent | |
| K212720 | nordicDSC | LLZ | Substantially Equivalent | |
| K191032 | fMRI Hardware System | LNH | Substantially Equivalent | |
| K163324 | nordicBrainEx | LLZ | Substantially Equivalent | |
| K140956 | LCD MONITOR | LNH | Substantially Equivalent | |
| K133910 | NORDICBRAINEX | LLZ | Substantially Equivalent | |
| K123306 | NORDIC TUMOREX | LLZ | Substantially Equivalent | |
| K092253 | MODIFICATION TO FMRI HARDWARE SYSTEM | LNH | Substantially Equivalent | |
| K080515 | FMRI HARDWARE SYSTEM | LNH | Substantially Equivalent | |
| K073099 | FMRI HARDWARE SYSTEM | LNH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006738448 | 3006738448 | NORDICNEUROLAB AS | MOLLENDALSVEIEN 1, BERGEN Hordaland 5009 NO | 2026 | |
| 3007319065 | 3007319065 | NordicNeuroLab INC. | 234 W FLORIDA ST STE 202, Milwaukee, WI 53204 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1462-2022 | nordicBrainEX, software versions 2.21 through 2.3.10 | When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right sides flipped. | Class II | Terminated | |
| Z-3023-2018 | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1 | Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner). | Class II | Terminated | |
| Z-2103-2018 | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone. | Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones. | Class II | Terminated | |
| Z-2061-2018 | 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. | 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. | Class II | Terminated | |
| Z-2042-2018 | nordicTumorEx 1.0 nordicTumorEx 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging datasets of the brain, showing properties of changes in contrast overtime. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be sued to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process. | 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. | Class II | Terminated | |
| Z-2050-2018 | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. | 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. | Class II | Terminated | |
| Z-2044-2018 | nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. | 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. | Class II | Terminated | |
| Z-2045-2018 | nordicBrainEX Product Usage: nordicBrainEx 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. | There is an error related to the relative geometry between fiber tracts in a fiber group and images. The error occurs in the following situations: A group of fibers has been selected using the VOI functionality and put into a fiber group. This is done with images series A visualized in the 3D viewer. Then a new images series B is visualized in the 3D viewer. If image series A and B have the same geometrical resolution (pixel sizes and slice distances), the coregistration matrix taking A to B will not be applied to the fiber group, and therefore the fiber group will in general not be positioned correctly on B in the 3D viewer. Furthermore, if the fiber group is exported as a new image series the fibers could be misplaced, and similarly if the fibers are visualized in the MPR on B, the positioning will not be correct. The misalignment will be equal to the rotations/translations necessary to align A with B. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain