# K123306: Nordic Tumorex

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab
- Decided: May 20, 2013 after 208 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K896095 (1990). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090546: Modification to Nordicice Software, Nordicimaginglab AS (2009) Summary page 2.
- K111161: Perfscape V2.0, Olea Medical (2011) Summary page 2.

## Recalls of this device
- Dec 15, 2014 · Class II · Z-2042-2018: 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
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" 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. nordicTumorEx software enables processing and visualization of dynamic MR imaging dlatasets of the brain, showing properties of changes in contrast over time. It generates various parametric images calculated from the image intensity variations and provides tools to extract and visualize such parametric properties within specified volumes of interest. Structural datasets providing anatomical information can be used to evaluate the extent of a specified sub-volume, such as a tumor. Comparison of imaging studies performed at different study dates may also be performed to support the diagnostic process.

Source page: https://510kreport.com/device/K123306
Methodology: https://510kreport.com/methodology