# K133910: Nordicbrainex

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab
- Decided: Apr 4, 2014 after 102 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: 8 generations back to K896095 (1990). 9 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 15 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 1.

## Most influential descendants
- K171754: NovaPACS (2017), 4 descendants of its own
- K231662: Aid-U (2024), 1 descendant of its own
- K221796: Cyware 4H and Cysart 4H (2022), 1 descendant of its own
- K250039: HPACS (2025), 0 descendants of its own
- K243069: Lumys (V1) (2025), 0 descendants of its own

## Recalls of this device
- Jun 16, 2022 · Class II · Z-1462-2022: When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, the resulting output may have left/right s
- Sep 17, 2014 · Class II · Z-2050-2018: 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
nordicBrainEx provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

Source page: https://510kreport.com/device/K133910
Methodology: https://510kreport.com/methodology