# K052029: Syngo Circulation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Aug 9, 2005 after 13 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: 3 generations back to K000315 (2000). 5 ancestors in all.
296 later devices descend from it; 2 cite it directly.
1 of 302 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041267: Cardiq Analysis Iii, General Electric Medical Systems (2004) Summary page 2.

## Most influential descendants
- K063762: Syngo Circulation Software Package with Extended Functionality (2007), 263 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own

## Indications for use
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions. These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

Source page: https://510kreport.com/device/K052029
Methodology: https://510kreport.com/methodology