# K042203: Leonardo Syngo Cardiology Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 24, 2004 after 39 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010938 (2001). 2 ancestors in all.
165 later devices descend from it; 5 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K061995: Xcelera (2006), 128 descendants of its own
- K083348: Image-Arena Applications (2008), 89 descendants of its own
- K090461: Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 (2009), 86 descendants of its own
- K120135: 2D Cardiac Performance Analysis MR 1.0 (2012), 82 descendants of its own
- K110746: 4D LV-Analysis 3.0 (2011), 80 descendants of its own

## Indications for use
The LEONARDO syngo Cardiology Workstation is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media. The LEONARDO syngo Cardiology Workstation can be configured as a stand-alone diagnostic review and post-processing workstation with a variety of syngo or Windows based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.

Source page: https://510kreport.com/device/K042203
Methodology: https://510kreport.com/methodology