# K042995: X-Leonardo

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 24, 2004 after 23 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.
41 later devices descend from it; 2 cite it directly.
0 of 44 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
- K143319: Syngo X-workplace SW VD10 (2015), 39 descendants of its own
- K153346: syngo Application Software VD11 (2016), 38 descendants of its own
- K162541: syngo Application Software (2016), 35 descendants of its own
- K163286: ARTIS pheno (2017), 23 descendants of its own
- K133580: Artis One (2014), 11 descendants of its own

## Indications for use
The X-LEONARDO is a medical diagnostic workstation for viewing, manipulation, communication, and storage of medical images and data on exchange media. The X-LEONARDO can be configured as a stand-alone diagnostic post-processing and reporting workstation. The X-LEONARDO can be configured 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 and OEM options

Source page: https://510kreport.com/device/K042995
Methodology: https://510kreport.com/methodology