510(k) · Cleared
Recalled · Class II · 2014Syngo Imaging Version V20A
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 Sep 22, 2005 as substantially equivalent to K042832 (Siemens AG Medical Solutions, 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 22, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 5 generations to K924178 (1993). 18 ancestors in all, the oldest K920309 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924178 Medvision (TM) Imaging SoftwareEvergreen Technologies, Inc. · 1993
- 4 generations backK970064 Amicas Web/Intranet Image ServerAutocyt Group, Inc. · 1997
- 3 generations backK973131 Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway)Siemens Medical Solutions USA, Inc. · 1997
- 2 generations backK033831 Sienet CosmosSiemens AG Medical Solutions · 2003 · Recalled
- 1 generation backK042832 Sienet Cosmos (Version V15A)Siemens AG Medical Solutions · 2004 · Recalled
- This deviceK052461 Syngo Imaging Version V20ASiemens AG Medical Solutions · 2005
- Descendant · cites it directly · 0 of its ownK070796 Chili PacsChili GmbH · 2007
- Descendant · cites it directly · 0 of its ownK060210 MediportMaxant Technologies, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924178 | Medvision (TM) Imaging Software | Evergreen Technologies, Inc. | 1993 | — |
| −4 | K970064 | Amicas Web/Intranet Image Server | Autocyt Group, Inc. | 1997 | — |
| −3 | K973131 | Sienet Magicweb (Web Server), Sienet Magiclink I (Isi-Gateway) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −2 | K033831 | Sienet Cosmos | Siemens AG Medical Solutions | 2003 | 1 |
| −1 | K042832 | Sienet Cosmos (Version V15A) | Siemens AG Medical Solutions | 2004 | 3 |
| 0 (this device) | K052461 | Syngo Imaging Version V20A | Siemens AG Medical Solutions | 2005 | — |
| +1 | K070796 | Chili Pacs | Chili GmbH | 2007 | — |
| +1 | 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 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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? (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 | Decided |
|---|---|---|---|
| * | K042832 | Sienet Cosmos (Version V15A)Summary page 3…ication, is substantially equivalent to the following commercially available devices: Siemens SIENET Cosmos K042832 Siemens LEONARDO K040970 Siemens MatrmoRe… | 2004 |
| * | K040970 | LeonardoSummary page 3…Siemens SIENET Cosmos K042832 Siemens LEONARDO K040970 Siemens MatrmoReport Softeopy Workstation K042868 The syngo® Imaging described in this… | 2004 |
| * | K042868 | Mammoreport Softcopy WorkstationSummary page 3…Siemens LEONARDO K040970 Siemens MatrmoReport Softeopy Workstation K042868 The syngo® Imaging described in this 5 10(k) has the same intended use and similar technical characteristics as the devices list… | 2005 |
| † | K042605 | Colongraphy Software Package with Extended Functionality | 2004 |
| † | K042221 | Coronis 5MP Medical Flat Panel Display System | 2004 |
| † | K043122 | SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel Display | 2005 |
| † | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5I | 2003 |
What descends from it? (2)
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. |
| Aug 22, 2008 | Not classified | Z-0102-2009 | Software design | Image may not be visible after merge. |
| Sep 5, 2006 | Not classified | Z-0070-2007 | Other | Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 8 of the 18 ancestors have a recall of any class.
- Of its descendants, K070796 (Chili GmbH, 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042832.
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?
syngo®Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.
It supports the physician in diagnosis and treatment planning.
syngo® Imaging also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo®Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows.
Enhanced syngo®Imaging workplaces use a variety of advanced postprocessing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052461: Syngo Imaging Version V20A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052461
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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