# K110366: Syngo.CT Cardiac Function

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Apr 12, 2011 after 64 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K971684 (1997). 30 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063762: Syngo Circulation Software Package with Extended Functionality, Siemens AG Medical Solutions (2007) Summary page 2.
- K092519: Syngo.X, Siemens AG Medical Solutions (2009) Summary page 2.
- K073153: Cardiq Function Xpress, GE Medical Systems SCS (2008) Summary page 2.
- K073138: Cardiq Express Version 2.0, GE Medical Systems (2008) Summary page 2.

## Most influential descendants
- K123585: Syngo, CT Cardiac Function (2012), 14 descendants of its own
- 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
- K112531: Vitrea CT Myocardial Analysis (2011), 6 descendants of its own

## Recalls of this device
- Mar 21, 2019 · Class II · Z-1112-2019: There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

## Indications for use
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the Software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding. These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.

Source page: https://510kreport.com/device/K110366
Methodology: https://510kreport.com/methodology