# K082441: Nordicice Software

- Pathway: 510(k) (Traditional)
- Applicant: Nordicimaginglab AS
- Decided: Nov 21, 2008 after 88 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896095 (1990). 7 ancestors in all.
73 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063539: Nordic Image Control and Evaluation (Nice) Software, Version 2.1, Nordicicemedical AS (2007) Summary page 1.

## Most influential descendants
- K090546: Modification to Nordicice Software (2009), 72 descendants of its own
- K111161: Perfscape V2.0 (2011), 53 descendants of its own
- K120196: Olea Sphere (2012), 51 descendants of its own
- K121447: Ischema View Rapid (2013), 29 descendants of its own
- K132095: Olea Sphere (2013), 20 descendants of its own

## Recalls of this device
- Jul 3, 2015 · Class II · Z-2061-2018: 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 accordin
- Sep 12, 2014 · Class II · Z-2044-2018: 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 

## Indications for use
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. BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity. DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain. Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.

Source page: https://510kreport.com/device/K082441
Methodology: https://510kreport.com/methodology