510(k) · Cleared

Recalled · 2006

Kinetdx

K041029510(k) TraditionalCleared Jul 8, 200478-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 Medi Cal Solutions, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jul 8, 2004 as substantially equivalent to K023772 (Acuson Corp., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 4 generations to 1995. 13 later devices descend from it. It has been recalled once.

Decided: Jul 8, 2004
Review: 78 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 2

Its longest line of descent runs back 4 generations to K950279 (1995). 8 ancestors in all, the oldest K925965 (1993). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK950279 TOMTECP90Tomtec Imaging Systems, Inc. · 1995
3 generations backK964803 Univision Echocardiology SystemNetwork Concepts, Inc. · 1997
2 generations backK980060 EcholinkMpacs, LLC · 1998
1 generation backK992259 Echocardiography System Series 95000Camtronics, Ltd. · 1999
This deviceK041029 KinetdxSiemens Medi Cal Solutions, Inc. · 2004
Descendant · cites it directly · 7 of its ownK053133 Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 2 generations on · 6 of its ownK111319 Ibis Explorer and Markup SoftwareMedqia · 2011
Descendant · 3 generations on · 5 of its ownK122205 EXINIExini Diagnostics AB · 2012
Descendant · cites it directly · 3 of its ownK050943 GE ViewpointGeneral Electric Co. · 2005 · Recalled
Descendant · 4 generations on · 2 of its ownK191262 aBSIExini Diagnostics AB · 2019

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2005high 3 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 13 · See all

K053133Syngo Dynamics, Version 5.0Siemens Medical Solutions USA, Inc. · 2005 · cites it directly7descendants
K111319Ibis Explorer and Markup SoftwareMedqia · 2011 · 2 generations on6descendants
K122205EXINIExini Diagnostics AB · 2012 · 3 generations on5descendants
K050943GE ViewpointGeneral Electric Co. · 2005 · cites it directly3descendants
K191262aBSIExini Diagnostics AB · 2019 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K950279	TOMTECP90	Tomtec Imaging Systems, Inc.	1995	—
−3	K964803	Univision Echocardiology System	Network Concepts, Inc.	1997	—
−2	K980060	Echolink	Mpacs, LLC	1998	—
−1	K992259	Echocardiography System Series 95000	Camtronics, Ltd.	1999	—
0 (this device)	K041029	Kinetdx	Siemens Medi Cal Solutions, Inc.	2004	—
+1	K053133	Syngo Dynamics, Version 5.0	Siemens Medical Solutions USA, Inc.	2005	2
+2	K111319	Ibis Explorer and Markup Software	Medqia	2011	—
+3	K122205	EXINI	Exini Diagnostics AB	2012	—
+1	K050943	GE Viewpoint	General Electric Co.	2005	1
+4	K191262	aBSI	Exini Diagnostics AB	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1996	2	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2010	1	0
2011	2	0
2012	1	0
2016	1	0
2018	1	0
2019	1	0
2021	1	0
2022	1	0
2024	1	0

FIG. 1 — Lineage of K041029, 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? (2)

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
*	K023772	Kinetdx Picture Archiving and Communications System Summary page 2 …Summary This premarket notification addresses an upgrade and modification of the KinetDx Picture Archival and Communications System as described in K023772 (cleared on 11/22/02). KinetDx in addition provides advanced reporting features, cardiology features for revi…	Acuson Corp.	2002	5
*	K992259	Echocardiography System Series 95000 Summary page 2 …KinetDx Picture Archiving K023772 11/22/02 Communication System Camtronics Echocardiography System K992259 09/08/99 Series 95000 In summary, Siemens is of the opinion that KinetDx does not introduce…	Camtronics, Ltd.	1999	—

Also cleared against K023772: 2 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K053133	Syngo Dynamics, Version 5.0	Siemens Medical Solutions USA, Inc.	2005	7
K050943	GE Viewpoint	General Electric Co.	2005	3
K051853	Cardiostream Sonoaim	Cardiostream, LLC	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 6, 2006	Not classified	Z-1235-06	Other	The cardiologist's report comments may not be retained by the system due to a software bug.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K053133 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K023772.

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 intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041029 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041029: Kinetdx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041029

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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