# K241608: nordicMEDiVA

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Jun 28, 2024 after 24 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: 9 generations back to K896095 (1990). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163324: nordicBrainEx, Nordicneurolab AS (2017) Summary page 5.
- K212720: nordicDSC, Nordicneurolab AS (2022) Summary page 5.

## Most influential descendants
- K243209: nordicMEDiVA (2024), 0 descendants of its own

## Indications for use
nordicMEDiVA is indicated for image analysis and visualization of functional and dynamic MRI data of the brain, presenting derived properties and parameters from the input image data in a clinically useful context.

Source page: https://510kreport.com/device/K241608
Methodology: https://510kreport.com/methodology