# K253786: syngo.CT Coronary Cockpit

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 25, 2026 after 211 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: 13 generations back to K913770 (1991). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202280: Cleerly Labs v2.0, Cleerly, Inc. (2020) Summary page 5.

## Indications for use
syngo.CT Coronary Cockpit is an image analysis software package for evaluating cardiac CT angiography volume data sets. Combining automated and semi-automated image processing, visualization and reporting tools, the software package is designed to assist the physician in confirming the presence or absence of coronary lesions and their evaluation, documentation, follow-up as well as treatment planning.

Source page: https://510kreport.com/device/K253786
Methodology: https://510kreport.com/methodology