# K090546: Modification to Nordicice Software

- Pathway: 510(k) (Traditional)
- Applicant: Nordicimaginglab AS
- Decided: Jun 8, 2009 after 98 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896095 (1990). 8 ancestors in all.
72 later devices descend from it; 9 cite 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)
- K082441: Nordicice Software, Nordicimaginglab AS (2008) Summary page 1.

## Most influential descendants
- 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
- K172477: iSchemaView RAPID (2018), 17 descendants of its own

## 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 of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.

Source page: https://510kreport.com/device/K090546
Methodology: https://510kreport.com/methodology