510(k) Report

FDA applicant

Nordicimaginglab AS

Bergen, Hordaland, NO3 decisions2008–20093 recalls

FDA records 3 decisions for Nordicimaginglab AS (Bergen, Hordaland, NO) from 2008 to 2009: 3 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 3 predicates, 2 of them its own earlier devices. 3 recalls are linked to its devices.

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 Nordicimaginglab AS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 12009: 2
2008high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2015

2012: 12014: 12015: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Nordicimaginglab AS by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Nordicimaginglab 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?

  • LLZSystem, Image Processing, Radiological3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 2 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.

  • K090546Modification to Nordicice SoftwareNordicimaginglab AS · 20099cite it
  • K082441Nordicice SoftwareNordicimaginglab AS · 20081cites it

What has FDA decided for it lately?

  • K092102Nordicbrainex Software, Version 1.0Nordicimaginglab AS · 20091 recall
  • K090546Modification to Nordicice SoftwareNordicimaginglab AS · 2009
  • K082441Nordicice SoftwareNordicimaginglab AS · 20082 recalls

All 3 as Nordicimaginglab AS →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K082441nordicICE v 2.3.14 nordicICE is an image processing software package to be used by…Jul 3, 2015Class II
  • K082441nordicICE 2.3.14 Image processing software package used by trained professionals…Sep 12, 2014Class II
  • K092102nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be…Dec 21, 2012Class II