510(k) · Cleared

Recalled · 2008

Syngo Dynamics, Version 5.0

K053133510(k) TraditionalCleared Dec 5, 200527-day reviewClass II21 CFR 892.2050Recalls 2

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

Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological

Cleared on Dec 5, 2005 as substantially equivalent to K041029 (Siemens Medi Cal Solutions, Inc., 2004) and 2 other predicates after a 27-day review. Its family tree reaches back 5 generations to 1995. 7 later devices descend from it. It has been recalled 2 times.

Decided: Dec 5, 2005
Review: 27 days
Class: Class II
Product code: LLZ
Recalls: 2
Predicates: 3

Its longest line of descent runs back 5 generations to K950279 (1995). 28 ancestors in all, the oldest K913475 (1991). 7 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
4 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
3 generations backK980060 EcholinkMpacs, LLC · 1998
2 generations backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
1 generation backK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004 · Recalled
This deviceK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005
Descendant · cites it directly · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Descendant · 2 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
Descendant · 3 generations on · 2 of its ownK191262 aBSIExini Diagnostics AB · 2019
Descendant · 4 generations on · 1 of its ownK211655 aPROMISEExini Diagnostics AB · 2021
Descendant · 3 generations on · 1 of its ownK173444 Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 1 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all

K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · cites it directly6descendants
K122205EXINIExini Diagnostics AB · 2012 · 2 generations on5descendants
K191262aBSIExini Diagnostics AB · 2019 · 3 generations on2descendants
K211655aPROMISEExini Diagnostics AB · 2021 · 4 generations on1descendant
K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc. · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K950279	TOMTECP90	Tomtec Imaging Systems, Inc.	1995	—
−4	K964803	Univision Echocardiology System	Network Concepts, Inc.	1997	—
−3	K980060	Echolink	Mpacs, LLC	1998	—
−2	K992259	Echocardiography System Series 95000	Camtronics, Ltd.	1999	—
−1	K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	2004	1
0 (this device)	K053133	Syngo Dynamics, Version 5.0	Siemens Medical Solutions USA, Inc.	2005	—
+1	K111319	Ibis Explorer and Markup Software	Medqia	2011	—
+2	K122205	EXINI	Exini Diagnostics AB	2012	—
+3	K191262	aBSI	Exini Diagnostics AB	2019	—
+4	K211655	aPROMISE	Exini Diagnostics AB	2021	—
+3	K173444	Quantitative Total Extensible Imaging (QTxI)	Aiq Solutions, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1992	1	0
1993	2	0
1994	1	0
1996	5	0
1997	2	0
1998	3	0
2000	1	0
2002	3	0
2005	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2018	1	0
2019	1	0
2021	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K053133, 1995–2024Source: 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.

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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	2004	1
*	K051649	Vericis Cardiovascular Image and Information System, Model 4.0 Summary page 3 …Manufacturer Number Date Code VERICIS Cardiovascular Image and information System K051649 08/02/2005 LLZ Camtronics Medical Systems AscentialTM (formally Encomnpass' TM ) K050228 02/18/2…	Camtronics Medical Systems	2005	17
*	K050228	Agfa Heartlab Cardiovascular Summary page 3 …on System K051649 08/02/2005 LLZ Camtronics Medical Systems AscentialTM (formally Encomnpass' TM ) K050228 02/18/2005 LLZ Heartlab Inc 7. Summary of Technological Characteristics of the Principal Device as Compared…	Heartlab, Inc.	2005	22

Also cleared against K041029: 2 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111319	Ibis Explorer and Markup Software	Medqia	2011	6

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 23, 2008	Not classified	Z-0544-2009	Software design	If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
Jan 31, 2007	Not classified	Z-0652-2007	Other	The cardiac calculation feature may incorrectly calculate a derived V max value (reported out lower than it should be) and certain values imported into worksheets and reports may be incorrect due to a software defect.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
7 of the 28 ancestors have a recall of any class.
Of its descendants, K111319 (Medqia, 2011) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K041029.

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?

syngo Dynamics is a Picture Archiving and Communication System (PACS)

intended for acceptance, transfer, display, storage, archive and manipulation

of digital medical images, including quantification and report generation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053133: Syngo Dynamics, Version 5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053133

Report an extraction error

Are you the manufacturer?

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