# K251059: Syngo Carbon Clinicals (VA41)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthineers AG
- Decided: Oct 24, 2025 after 203 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: 16 generations back to K913770 (1991). 186 ancestors in all.
No later device cites it as a predicate yet.
3 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232856: Syngo Carbon Clinicals, Siemens Healthcare GmbH (2023) Summary page 5.

## Indications for use
Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.) OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements. The TimeLens provides the means to compare a region of interest between multiple time points. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities. An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Source page: https://510kreport.com/device/K251059
Methodology: https://510kreport.com/methodology