# K123585: Syngo, CT Cardiac Function

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 20, 2012 after 29 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954678 (1996). 90 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110366: Syngo.CT Cardiac Function, Siemens AG (2011) Summary page 2.
- K112020: Syngo.CT Vascular Analysis, Siemens Medi Cal Solutions, Inc. (2011) Summary page 2.
- K113027: Syngo Aortic Valveguide Software, Siemens Medical Solutions USA, Inc. (2011) Summary page 2.

## Most influential descendants
- K183268: AI-Rad Companion (Cardiovascular) (2019), 11 descendants of its own
- K210085: HealthCCSng (2021), 9 descendants of its own
- K230223: iCAC Device (2023), 6 descendants of its own
- K243229: Bunkerhill AVC (2025), 3 descendants of its own
- K170221: syngo.CT Cardiac Planning (2017), 1 descendant of its own

## Indications for use
syngo.CT Cardiac Function is an image analysis software package for evaluating CT images of the heart. Combining digital image processing and visualization tools (20, 3D and 4D display of dynamic data), evaluation tools (structural and functional analysis of heart chambers and valves, and analysis of myocardial tissue) and reporting tools, the software package is designed to support the physician in determining the functional and morphological parameters of the heart chambers, heart valves and confirming the presence or absence of physician-identified myocardial disease and evaluation, documentation and follow-up of any such finding.

Source page: https://510kreport.com/device/K123585
Methodology: https://510kreport.com/methodology