Data / Medical devices / Norway / Nordicneurolab AS

Nordicneurolab AS: FDA-registered device maker in BERGEN Hordaland, Norway, 6 510(k) clearances

Name: Nordicneurolab AS FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Nordicneurolab AS is registered with the FDA (registration 3006738448) in BERGEN Hordaland, Norway. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 20, 2026. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006738448
Address: Mollendalsveien 1, BERGEN Hordaland, Norway, 5009
Owner or operator: NORDICNEUROLAB AS (9098320)
Roles: Manufacturer
First device listed: February 15, 2017
Registered through: 2026
Brand names listed: NordicNeuroLab, fMRI hardware system, nordicAudio, nordicBrainEx, nordicMEDiVA

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 20, 2026	K251937	nordicAudio (1.0)	LNH	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov
October 22, 2024	K243209	nordicMEDiVA	LLZ	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov
June 28, 2024	K241608	nordicMEDiVA	LLZ	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov
December 13, 2023	K232680	fMRI Hardware System	LNH	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov
March 3, 2022	K212720	nordicDSC	LLZ	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov
January 27, 2017	K163324	nordicBrainEx	LLZ	Substantially Equivalent	Nordicneurolab AS	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 16, 2022	90480	Class II	Terminated	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.	accessdata.fda.gov
August 20, 2018	80529	Class II	Terminated	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 Powe	Complaints of this version of the power supply unit (LPS) (1.0 and 1.1) being dragged into the magnet bore (MR Scanner).	accessdata.fda.gov
October 28, 2017	78848	Class II	Terminated	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 o	Report was of an interrupted MR scan after patient complained about acoustic distortion, and heat felt form the headphones.	accessdata.fda.gov
July 3, 2015	78467	Class II	Terminated	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 w	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.	accessdata.fda.gov
December 15, 2014	78460	Class II	Terminated	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 P	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.	accessdata.fda.gov
September 17, 2014	78466	Class II	Terminated	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.	accessdata.fda.gov
September 12, 2014	78463	Class II	Terminated	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.	accessdata.fda.gov
December 21, 2012	80162	Class II	Terminated	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-	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.	accessdata.fda.gov

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Updated March 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.