# K260055: syngo.CT Brain Quantification

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 25, 2026 after 260 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)
- K211222: qER-Quant, Qure.Ai Technologies (2021) Summary page 6.

## Indications for use
syngo.CT Brain Quantification is a radiological post-processing application for the analysis of non-contrast head CT images. The device is intended for automatic labeling, visualization, and quantification of intracranial structures. The software is indicated for use in the analysis of: * Intracranial hyperdensities * Midline Shift The device is intended to be used in patients aged 18 years or above. No surgical signs must be present in the images.

Source page: https://510kreport.com/device/K260055
Methodology: https://510kreport.com/methodology