# K063762: Syngo Circulation Software Package with Extended Functionality

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Jan 5, 2007 after 16 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: 4 generations back to K913770 (1991). 11 ancestors in all.
263 later devices descend from it; 6 cite it directly.
1 of 275 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052029: Syngo Circulation, Siemens AG Medical Solutions (2005) Summary page 2.
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.
- K022013: Lungcare CT Software Package, Siemens Medical Solutions USA, Inc. (2002) Summary page 2.

## Most influential descendants
- K091373: Syngo Trued (2009), 200 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 descendants of its own

## Indications for use
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.

Source page: https://510kreport.com/device/K063762
Methodology: https://510kreport.com/methodology