510(k) Report

FDA applicant

Nordicneurolab AS

Bergen, NO13 decisions2007–20265 recalls

FDA records 13 decisions for Nordicneurolab AS (Bergen, NO) from 2007 to 2026: 13 510(k) clearances. Most are in product codes LNH (System, Nuclear Magnetic Resonance Imaging) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 103 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 9 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Nordicneurolab”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Nordicneurolab AS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2007: 12008: 12009: 12013: 12014: 22017: 12019: 12022: 12023: 12024: 22026 (partial year): 1
2007high 2 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2022

2014: 22017: 12018: 12022: 1
2007high 2 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Nordicneurolab AS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nordicneurolab AS’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LNHSystem, Nuclear Magnetic Resonance Imaging7decisions
  • LLZSystem, Image Processing, Radiological6decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 103 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 126 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K163324nordicBrainExNordicneurolab AS · 20174cite it
  • K073099Fmri Hardware SystemNordicneurolab · 20072cite it
  • K080515Fmri Hardware SystemNordicneurolab · 20082cite it
  • K092253Modification to Fmri Hardware SystemNordicneurolab · 20091cites it
  • K191032fMRI Hardware SystemNordicneurolab AS · 20191cites it
  • K212720nordicDSCNordicneurolab AS · 20221cites it

What has FDA decided for it lately?

  • K251937nordicAudio (1.0)Nordicneurolab AS · 2026
  • K243209nordicMEDiVANordicneurolab AS · 2024
  • K241608nordicMEDiVANordicneurolab AS · 2024
  • K232680fMRI Hardware SystemNordicneurolab AS · 2023
  • K212720nordicDSCNordicneurolab AS · 2022
  • K191032fMRI Hardware SystemNordicneurolab AS · 2019
  • K163324nordicBrainExNordicneurolab AS · 2017
  • K140956LCD MonitorNordicneurolab · 2014

All 7 as Nordicneurolab AS →All 6 as Nordicneurolab →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K133910nordicBrainEX, software versions 2.21 through 2.3.10Jun 16, 2022Class II
  • K092253fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC…Aug 20, 2018Class II
  • K080515fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals…Oct 28, 2017Class II
  • K123306nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by…Dec 15, 2014Class II
  • K133910nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data…Sep 17, 2014Class II