# K040970: Leonardo

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Jul 8, 2004 after 85 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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: 1 generation back to K010938 (2001). 1 ancestor in all.
420 later devices descend from it; 11 cite it directly.
1 of 422 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010938: Syngo Multimodality Workstation, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K062351: Syngo Dual Energy (2006), 169 descendants of its own
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K042203: Leonardo Syngo Cardiology Workstation (2004), 165 descendants of its own
- K061995: Xcelera (2006), 128 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own

## Recalls of this device
- Dec 21, 2007 · Not classified · Z-1038-2008: Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system.

## Indications for use
The LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-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/K040970
Methodology: https://510kreport.com/methodology