# K212720: nordicDSC

- Pathway: 510(k) (Traditional)
- Applicant: Nordicneurolab AS
- Decided: Mar 3, 2022 after 188 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.
2 later devices descend from it; 1 cites it directly.
0 of 12 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
- K243209: nordicMEDiVA (2024), 0 descendants of its own

## Indications for use
nordicDSC is a medical image post-processing software for the analysis of the dynamic time course of the dynamic susceptibility contrast (DSC) enhanced MR data of the human brain to be used by trained professionals such as physicians, radiologists, and medical technicians to yield information useful in clinical applications. The software is intended to be used off-line and in combination with a DICOM handling platform that can allow for user interactions, sending, receiving, and viewing of data, data quality control, and connection to network.

Source page: https://510kreport.com/device/K212720
Methodology: https://510kreport.com/methodology