510(k) · Cleared
Recalled · Class II · 2014Sienet Cosmos (Version V15A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · LLZ System, Image Processing, Radiological
Cleared on Oct 28, 2004 as substantially equivalent to K033831 (Siemens AG Medical Solutions, 2003) after a 15-day review. Its family tree reaches back 4 generations to 1993. 5 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 28, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924178 (1993). 12 ancestors in all, the oldest K920309 (1992). 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 3 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 2 generations backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 1 generation backK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
- This deviceK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004
- Descendant · cites it directly · 2 of its ownK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · Recalled
- Descendant · cites it directly · 1 of its ownK070755 InterworksAvreo, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK141556 Avreo Interworks SystemAvreo, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK070796 Chili PacsChili GmbH · 2007
- Descendant · 2 generations on · 0 of its ownK060210 MediportMaxant Technologies, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K052461Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005 · cites it directly2descendants
- K070755InterworksAvreo, Inc. · 2007 · cites it directly1descendant
- K141556Avreo Interworks SystemAvreo, Inc. · 2014 · 2 generations on0descendants
- K070796Chili PacsChili GmbH · 2007 · 2 generations on0descendants
- K060210MediportMaxant Technologies, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −3 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −2 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −1 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| 0 (this device) | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | — |
| +1 | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | 3 |
| +1 | K070755 | Interworks | Avreo, Inc. | 2007 | — |
| +2 | K141556 | Avreo Interworks System | Avreo, Inc. | 2014 | — |
| +2 | K070796 | Chili Pacs | Chili GmbH | 2007 | — |
| +2 | K060210 | Mediport | Maxant Technologies, Inc. | 2006 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K033831 | Sienet CosmosSummary page 3…ressed in this premarket notification, is sub- stantially equivalent to the following commercially available device: SIENET Cosmos K033831 The SIENET Cosmos described in this 510(k) has the same intended use and similar tech- nical characteristics as th… | 2003 |
What descends from it? (5)
2 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)
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 archiving method may have deleted data from archive itself. |
| Oct 3, 2006 | Not classified | Z-0069-2007 | Other | Potential loss of images. Images may not successfully be sent to the RAID system. |
| Sep 22, 2005 | Not classified | Z-0092-06 | Other | reference lines appear above actual position |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K052461 (Siemens AG Medical Solutions, 2005) has gone furthest, with 2 descendants of its own.
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 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 (172 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).
Note:
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/K042832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042832: Sienet Cosmos (Version V15A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042832
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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