# K211222: qER-Quant

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Jul 30, 2021 after 98 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 4 generations back to K061855 (2006). 4 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181939: icobrain, Icometrix NV (2018) Summary page 4.

## Most influential descendants
- K213165: Rapid (2022), 7 descendants of its own
- K233582: Rapid (2024), 3 descendants of its own
- K232363: Viz HDS, Viz Volume Plus, Viz ICH+ (2024), 2 descendants of its own
- K243350: Rapid Neuro3D (2025), 1 descendant of its own
- K233512: Rapid (6.0) (2024), 1 descendant of its own

## Indications for use
The qER-Quant device is intended for automatic labeling, visualization and quantification of segmentable brain structures from a set of Non-Contrast head CT (NCCT) images. The software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on NCCT images. qER-Quant provides volumes from NCCT images acquired at a single time point and provides a table with comparative analysis for two or more images that were acquired on the same scanner with the same image acquisition protocol for the same individual at multiple time points. The qER-Quant software is indicated for use in the analysis of the following structures: Intracranial Hyperdensities, Lateral Ventricles and Midline Shift.

Source page: https://510kreport.com/device/K211222
Methodology: https://510kreport.com/methodology