# K140828: Neuroreader Medical Image Processing Software

- Pathway: 510(k) (Traditional)
- Applicant: Brainreader Aps
- Decided: Feb 4, 2015 after 309 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K061855 (2006). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061855: Neuroquant, Cortechs Labs, Inc. (2006) Summary page 5.

## Most influential descendants
- K202847: AccuBrain (2021), 0 descendants of its own

## Recalls of this device
- Dec 14, 2020 · Class II · Z-0934-2021: The Neuroreader has been distributed with a reference normative database that is different from the version reviewed and cleared by FDA.

## Indications for use
The NeuroReader Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.

Source page: https://510kreport.com/device/K140828
Methodology: https://510kreport.com/methodology