510(k) · Cleared
ClearedLeonardo Syngo Cardiology Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 24, 2004 as substantially equivalent to K040970 (Siemens Medical Systems, Inc., 2004) after a 39-day review. Its family tree reaches back 2 generations to 2001. 165 later devices descend from it.
- Decided
- Sep 24, 2004
- Review
- 39 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010938 (2001). 165 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 1 generation backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- This deviceK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · 2 generations on · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- Descendant · 3 generations on · 86 of its ownK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- Descendant · 4 generations on · 82 of its ownK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- Descendant · 4 generations on · 80 of its ownK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
Showing 5 of 165 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 165 · See all- K061995XceleraPhilips Medical Systems North America Co. · 2006 · cites it directly128descendants
- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · 2 generations on89descendants
- K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH · 2009 · 3 generations on86descendants
- K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012 · 4 generations on82descendants
- K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011 · 4 generations on80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −1 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| 0 (this device) | K042203 | Leonardo Syngo Cardiology Workstation | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +2 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| +3 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| +4 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| +4 | K110746 | 4D LV-Analysis 3.0 | Tomtec Imaging Systems GmbH | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 25 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040970 | LeonardoSummary page 2…, addressed in this premarket notification, is substantially equivalent to the following commercially available device: LEONARDO (K040970) The LEONARDO syngo Cardiology Workstation described in this premarket notification has the same intended use and… | 2004 |
What descends from it? (165)
See all 1655 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K061995 (Philips Medical Systems North America Co., 2006) has gone furthest, with 128 descendants of its own.
- 10 other devices also cite its predicate K040970.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042203 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042203: Leonardo Syngo Cardiology Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042203
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026