# K231929: iQ-solutions

- Pathway: 510(k) (Traditional)
- Applicant: Sydney Neuroimaging Analysis Centre Pty, Ltd.
- Decided: Dec 18, 2023 after 171 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: 5 generations back to K061855 (2006). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192130: Icobrain, Icometrix NV (2019) Summary page 5.

## Indications for use
1Q-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. 1Q-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. » The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point. The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.

Source page: https://510kreport.com/device/K231929
Methodology: https://510kreport.com/methodology