510(k) · Cleared

Recalled · 2007

Leonardo

K040970510(k) TraditionalCleared Jul 8, 200485-day reviewClass II21 CFR 892.2050Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jul 8, 2004 as substantially equivalent to K010938 (Siemens Medical Solutions USA, Inc., 2001) after an 85-day review. Its family tree reaches back 1 generation to 2001. 1 of the 422 devices in its family, counting itself, has a Class I recall. 420 later devices descend from it. It has been recalled once.

Decided: Jul 8, 2004
Review: 85 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K010938 (2001). 420 later devices descend from it, 11 citing it directly. 1 of the 422 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
This deviceK040970 LeonardoSiemens Medical Systems, Inc. · 2004
Descendant · cites it directly · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
Descendant · 2 generations on · 168 of its ownK073003 Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008
Descendant · cites it directly · 165 of its ownK042203 Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004
Descendant · 2 generations on · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
Descendant · 3 generations on · 117 of its ownK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009

Showing 5 of 420 descendants. See all descendants

Descendants cleared per year

2004high 49 (2025) · low 2 (2004)2026

Class I recalls in this family

K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025

Most influential descendants

Showing 5 of 420 · See all

K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · cites it directly169descendants
K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc. · 2008 · 2 generations on168descendants
K042203Leonardo Syngo Cardiology WorkstationSiemens Medical Solutions USA, Inc. · 2004 · cites it directly165descendants
K061995XceleraPhilips Medical Systems North America Co. · 2006 · 2 generations on128descendants
K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009 · 3 generations on117descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010938	Syngo Multimodality Workstation	Siemens Medical Solutions USA, Inc.	2001	5
0 (this device)	K040970	Leonardo	Siemens Medical Systems, Inc.	2004	—
+1	K062351	Syngo Dual Energy	Siemens Medical Solutions USA, Inc.	2006	—
+2	K073003	Syngo Dual Energy with Extended Functionally	Siemens Medi Cal Solutions, Inc.	2008	—
+1	K042203	Leonardo Syngo Cardiology Workstation	Siemens Medical Solutions USA, Inc.	2004	—
+2	K061995	Xcelera	Philips Medical Systems North America Co.	2006	—
+3	K083524	Syngo Dual Energy with Extended Funationally	Siemens Medical Solutions USA, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	5	0
2006	6	0
2007	4	0
2008	4	0
2009	8	0
2010	5	0
2011	9	0
2012	14	0
2013	11	0
2014	13	0
2015	15	0
2016	16	0
2017	18	0
2018	24	0
2019	21	0
2020	38	0
2021	21	0
2022	35	0
2023	35	0
2024	32	0
2025	49	1
2026	35	0

FIG. 1 — Lineage of K040970, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

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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	Applicant	Decided	Recalls
*	K010938	Syngo Multimodality Workstation Summary page 2 …emarket notification, is substantially equivalent to the following commercially available device: syngo Multimodality Workstation (K010938) same The LEONARDO Workplace…	Siemens Medical Solutions USA, Inc.	2001	5

Also cleared against K010938: 12 other devices →

What descends from it? (420)

See all 420

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062351	Syngo Dual Energy	Siemens Medical Solutions USA, Inc.	2006	169
K042203	Leonardo Syngo Cardiology Workstation	Siemens Medical Solutions USA, Inc.	2004	165
K042995	X-Leonardo	Siemens Medical Solutions USA, Inc.	2004	41
K052305	Mri Soft Tissue Motion Correction Software VA10A	Siemens Medical Solutions USA, Inc.	2005	34
K060226	Oncor Expression	Siemens Medical Solutions USA, Inc.	2006	13
K053024	Syngo Neuro Dsa CT	Siemens AG	2005	8
K042868	Mammoreport Softcopy Workstation	Siemens Medical Solutions USA, Inc.	2005	7
K060633	Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0	Siemens Medical Solutions USA, Inc.	2006	5
K131447	Intuition - Tda, Tva, Parametric Mapping	Terarecon,Inc.	2013	2
K052461	Syngo Imaging Version V20A	Siemens AG Medical Solutions	2005	2

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 21, 2007	Not classified	Z-1038-2008	Software design	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.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K062351 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 169 descendants of its own.
12 other devices also cite its predicate K010938.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)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 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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040970 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040970: Leonardo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040970

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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