# K163324: nordicBrainEx

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Jan 27, 2017 after 63 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: 8 generations back to K896095 (1990). 9 ancestors in all.
5 later devices descend from it; 4 cite 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 4.

## Most influential descendants
- K241608: nordicMEDiVA (2024), 1 descendant of its own
- K202808: Brainance MD (2021), 1 descendant of its own
- K243209: nordicMEDiVA (2024), 0 descendants of its own
- K222975: Advantis Platform (2023), 0 descendants of its own
- K221426: Functional MR V1.0 (2022), 0 descendants of its own

## 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/K163324
Methodology: https://510kreport.com/methodology