# K243209: nordicMEDiVA

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Oct 22, 2024 after 21 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: 10 generations back to K896095 (1990). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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 7.
- K241608: nordicMEDiVA, Nordicneurolab AS (2024) Summary page 7.
- K203518: Quicktome, Omniscient Neurotechnology Pty Ltd (O8t) (2021) Summary page 5.

## Indications for use
Intended use The nordicMEDiVA software is an advanced visualization and processing platform with a specific focus on providing algorithms designed to analyze functional and dynamic MRI data of the brain. The software runs on a server in a networked environment and is accessed by users via a standard web browser. It can communicate with other imaging platforms that support DICOM, and process medical image data acquired through DICOM-compliant imaging devices and modalities. Intended users nordicMEDiVA must be operated according to its intended purpose and only by qualified medical personnel with the necessary knowledge in accordance with country-specific regulations, such as trained radiological technicians or physicians. Users must have received training in applicable areas, such as in MR technology and neuroanatomy. 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. Contraindications The software is not be used as an archiving device for patients' image data. The software is not to be used as a sole basis for clinical decisions, but further evidence has to be taken into account. The software is not to be used as a sole basis in emergency care applications. The software is not to be used for applications other than the analysis and visualization of MR data, or data derived thereof, of the human brain. Patient target population nordicMEDiVA has no limitation concerning the patient population.

Source page: https://510kreport.com/device/K243209
Methodology: https://510kreport.com/methodology