# K100637: Syngo.CT Coronary Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: May 26, 2010 after 82 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: 7 generations back to K971684 (1997). 29 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 32 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.
- K073138: Cardiq Express Version 2.0, GE Medical Systems (2008) Summary page 2.

## Most influential descendants
- K173637: syngo.CT Coronary Analysis; syngo.CT Vascular Analysis (2018), 1 descendant of its own
- K220910: Medical image processing software (2022), 0 descendants of its own

## Indications for use
Syngo.CT Coronary is an image analysis software package for evaluating cardiac C'T 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), curved planar reformation (CPR)), evaluation tools (coronary vessel centerline calculation, stenosis calculation and plaque analysis) and reporting tools (lesion location, lesion characteristics and key images), the software package is designed to support the physician in confirming the presence or absence of physician-identified coronary lesions and evaluation, documentation and follow-up of any such lesion. These visualization/evaluation tools allow for characterization of coronary lesions and lesion size over time, helping the physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue.

Source page: https://510kreport.com/device/K100637
Methodology: https://510kreport.com/methodology