# K202808: Brainance MD

- Pathway: 510(k) (Traditional)
- Applicant: Advantis Medical Imaging Single Member P.C.
- Decided: Oct 14, 2021 after 386 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). 10 ancestors in all.
1 later device descends 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)
- K163324: nordicBrainEx, Nordicneurolab AS (2017) Summary page 4.

## Most influential descendants
- K222975: Advantis Platform (2023), 0 descendants of its own

## Indications for use
Brainance MD 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/K202808
Methodology: https://510kreport.com/methodology