510(k) · Cleared

Recalled · Class II · 2014

Sienet Cosmos

K033831510(k) TraditionalCleared Dec 19, 20039-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 AG Medical Solutions · LLZ System, Image Processing, Radiological

Cleared on Dec 19, 2003 as substantially equivalent to K920309 (Siemens Gammasonics, Inc., 1992) and 5 other predicates after a 9-day review. Its family tree reaches back 3 generations to 1993. 6 later devices descend from it. It has been recalled once.

Decided: Dec 19, 2003
Review: 9 days
Class: Class II
Product code: LLZ
Recalls: 1
Predicates: 6

Its longest line of descent runs back 3 generations to K924178 (1993). 11 ancestors in all, the oldest K920309 (1992). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
2 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
1 generation backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
This deviceK033831 Sienet CosmosSiemens AG Medical Solutions · 2003
Descendant · cites it directly · 5 of its ownK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
Descendant · 2 generations on · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
Descendant · 2 generations on · 1 of its ownK070755 InterworksAvreo, Inc. · 2007
Descendant · 3 generations on · 0 of its ownK141556 Avreo Interworks SystemAvreo, Inc. · 2014
Descendant · 3 generations on · 0 of its ownK070796 Chili PacsChili GmbH · 2007

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all

K042832Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · cites it directly5descendants
K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · 2 generations on2descendants
K070755InterworksAvreo, Inc. · 2007 · 2 generations on1descendant
K141556Avreo Interworks SystemAvreo, Inc. · 2014 · 3 generations on0descendants
K070796Chili PacsChili GmbH · 2007 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K924178	Medvision (TM) Imaging Software	Evergreen Technologies, Inc.	1993	—
−2	K970064	Amicas Web/Intranet Image Server	Autocyt Group, Inc.	1997	—
−1	K973131	Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)	Siemens Medical Solutions USA, Inc.	1997	—
0 (this device)	K033831	Sienet Cosmos	Siemens AG Medical Solutions	2003	—
+1	K042832	Sienet Cosmos (Version V15A)	Siemens AG Medical Solutions	2004	3
+2	K052461	Syngo Imaging Version V20A	Siemens AG Medical Solutions	2005	3
+2	K070755	Interworks	Avreo, Inc.	2007	—
+3	K141556	Avreo Interworks System	Avreo, Inc.	2014	—
+3	K070796	Chili Pacs	Chili GmbH	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	2	0
1994	1	0
1995	2	0
1996	1	0
1997	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	2	0
2014	1	0

FIG. 1 — Lineage of K033831, 1993–2014Source: 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

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What was it cleared against? (6)

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
*	K920309	Sienet Diagnostic Reporting Console Summary page 3 …fication, is substantially equiva- lent to the following commercially available devices: SIENET Diagnostic Reporting Console (DRC) K920309 SIENET Diagnostic Reporting Console VA02 Upgrade K935694 SIENET Teleradiology Product Line…	Siemens Gammasonics, Inc.	1992	—
*	K935694	Sienet Diagnostic Reporting Console VA02 Upgrade Summary page 3 …ailable devices: SIENET Diagnostic Reporting Console (DRC) K920309 SIENET Diagnostic Reporting Console VA02 Upgrade K935694 SIENET Teleradiology Product Line K955394 syngo®Multimodality Workstation…	Siemens Medical Solutions USA, Inc.	1994	4
*	K955394	Sienet Teleradiology Product Line Summary page 3 …K920309 SIENET Diagnostic Reporting Console VA02 Upgrade K935694 SIENET Teleradiology Product Line K955394 syngo®Multimodality Workstation K010938 SIENET MagicWeb (Webserver), SIENET Magic…	Siemens Medical Solutions USA, Inc.	1996	2
*	K010938	Syngo Multimodality Workstation Summary page 3 …K935694 SIENET Teleradiology Product Line K955394 syngo®Multimodality Workstation K010938 SIENET MagicWeb (Webserver), SIENET MagicLink I K973131 SIENET Archive Server, ISA I, ISA II, Sto…	Siemens Medical Solutions USA, Inc.	2001	5
*	K973131	Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) Summary page 3 …K955394 syngo®Multimodality Workstation K010938 SIENET MagicWeb (Webserver), SIENET MagicLink I K973131 SIENET Archive Server, ISA I, ISA II, Storage Server K920310 The SIENET Cosmos described in this 510(…	Siemens Medical Solutions USA, Inc.	1997	—
*	K920310	Sienet Archive Server, Isa I, Isa II Storage Serve Summary page 3 …K010938 SIENET MagicWeb (Webserver), SIENET MagicLink I K973131 SIENET Archive Server, ISA I, ISA II, Storage Server K920310 The SIENET Cosmos described in this 510(k) has the same intended use and similar tech- nical characteristics as…	Siemens Gammasonics, Inc.	1992	1

What descends from it? (6)

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

Number	Device	Applicant	Decided	Descendants
K042832	Sienet Cosmos (Version V15A)	Siemens AG Medical Solutions	2004	5

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 3, 2014	Class II	Z-1622-2014	Use error	A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
4 of the 11 ancestors have a recall of any class.
Of its descendants, K042832 (Siemens AG Medical Solutions, 2004) has gone furthest, with 5 descendants of its own.

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 SIENET Cosmos is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e. * Manipulating • Reading • Reporting * Viewing * Communicating / distributing * Storing / archiving of radiological softcopy images and * Storing / archiving of structured (DICOM) reports. The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning. Therefore SIENET Cosmos…

Read the full statement (171 words)

The SIENET Cosmos is a Picture Archiving and Communication System (PACS) intended to enhance the complete imaging workflow, i.e.

* Manipulating

• Reading

• Reporting

* Viewing

* Communicating / distributing

* Storing / archiving

of radiological softcopy images and

* Storing / archiving of structured (DICOM) reports.

The system is a "software only" solution and is intended to assist the physician in diagnosis or treatment planning.

Therefore SIENET Cosmos supports the following generic imaging workflow:

• Receive scheduled exams from IS at the SIENET Cosmos archiving component SDM

· Provide relevant prior exams and reports (Structured Reports only) to the Modalities and Workplaces

* Receive and store new exams from the Modalities at the SDM

· Prepare images for reading

· Report new images, if required by comparing them with prior exams and reports

* Demonstrate exams at Radiological Demos

* View exams and reports at Workplaces outside Radiology (e.g. Surgery, Intensive Case Unit, wards, external referring physicians).

The workstation deployment syngo Viewing Studio is not intended for primary diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033831 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033831: Sienet Cosmos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033831

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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