# K202847: AccuBrain

- Pathway: 510(k) (Traditional)
- Applicant: Brainnow Medical Technology Limited
- Decided: Jan 15, 2021 after 112 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: 2 generations back to K061855 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170981: NeuroQuant, Cortechs Labs, Inc. (2017) Summary page 4.
- K140828: Neuroreader Medical Image Processing Software, Brainreader Aps (2015) Summary page 4.

## Indications for use
AccuBrain is a fully automated post-processing software that provides automatic labeling, visualization and volumetric quantification of hippocampus from a set of MRIs and returns an analysis report.

Source page: https://510kreport.com/device/K202847
Methodology: https://510kreport.com/methodology