510(k) · Cleared
Recalled · Class II · 2015Syngo Imaging XS
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 Nov 14, 2008 as substantially equivalent to K071114 (Siemens AG Medical Solutions, 2007) and 1 other predicate after an 84-day review. Its family tree reaches back 5 generations to 1995. 11 later devices descend from it. It has been recalled 12 times.
- Decided
- Nov 14, 2008
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 5 generations to K945188 (1995). 7 ancestors in all. 11 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 3 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 1 generation backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- This deviceK082430 Syngo Imaging XSSiemens AG Medical Solutions · 2008
- Descendant · cites it directly · 10 of its ownK093612 Syngo.PlazaSiemens AG Medical Solutions · 2010 · Recalled
- Descendant · 2 generations on · 9 of its ownK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- Descendant · 3 generations on · 8 of its ownK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- Descendant · 4 generations on · 6 of its ownK142750 JiveXVisus Technology Transfer GmbH · 2015
- Descendant · 5 generations on · 4 of its ownK162008 JiveXVisus Technology Transfer GmbH · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K093612Syngo.PlazaSiemens AG Medical Solutions · 2010 · cites it directly10descendants
- K101666Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · 2 generations on9descendants
- K132532Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · 3 generations on8descendants
- K142750JiveXVisus Technology Transfer GmbH · 2015 · 4 generations on6descendants
- K162008JiveXVisus Technology Transfer GmbH · 2016 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −4 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −3 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −2 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −1 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| 0 (this device) | K082430 | Syngo Imaging XS | Siemens AG Medical Solutions | 2008 | — |
| +1 | K093612 | Syngo.Plaza | Siemens AG Medical Solutions | 2010 | 16 |
| +2 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| +3 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| +4 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| +5 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 | Decided |
|---|---|---|---|
| * | K071114 | Syngo Imaging (Version V30)Summary page 3…tion, is substantially equivalent to the following commercially available devices: Siemens syngo Imaging V30 K071114 Mercury VISAGE Pacs/CS K072205 The syngo Imaging XS describe… | 2007 |
| * | K072205 | Visage Pacs/CS, Release Version 5.0Summary page 3…mens syngo Imaging V30 K071114 Mercury VISAGE Pacs/CS K072205 The syngo Imaging XS described in this 510(k) has the same intended use and similar technical characteristics as the dev… | 2007 |
| † | 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? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093612 | Syngo.Plaza | 2010 | 10 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 17, 2015 | Class II | Z-0550-2016 | Software in the Use Environment | For the Syngo Workflow SLR System with Software Ver: VB10C: Printouts may be printed in incorrect anatomical size when using syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This… |
| Nov 11, 2014 | Class II | Z-0576-2015 | Component design/selection | Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS filming application in conjunction with a printer not released for anatomical print usage. This may happen due to an invalid combination of… |
| Jun 30, 2014 | Class II | Z-2111-2014 | Software design | Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest , Pixel Lens , Edge… |
| Jul 18, 2012 | Class II | Z-2264-2012 | Software design | There is a potential malfunction when using syngo Imaging XS, version VA70A or higher. In some situations it can happen that a miscalculation is done for the grey scale values in the functions "Regions of Interest", "Pixel Lens", "Edge… |
| Jan 26, 2012 | Not classified | Z-1064-2012 | Software design | In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional… |
| Sep 20, 2011 | Not classified | Z-0514-2012 | Labeling False and Misleading | Unintended behavior when using syngo Imaging XS, all versions. The "Rename" functionality can cause an unintended patient merge if the renamed patient is sent to another system. |
| Sep 19, 2011 | Not classified | Z-0515-2012 | Software design | Unintended behavior when using syngo Imaging XS, versions VA70A and VA70B Client/Serve installations. Loading additional images/series from Patient Browser using the thumbnails can cause an unintended deletion of images/series. |
| Apr 6, 2010 | Not classified | Z-1892-2010 | Device Design | Siemens has become aware of a potential malfunction and hazard to patients when using Syngo Imaging version lines VB20, VB30, VB35A in combination with a RIS that is violating DICOM Standard by creating non-unique study instance UIDs. |
| Feb 16, 2010 | Not classified | Z-1423-2010 | Software design | images can be overwritten |
| Sep 30, 2009 | Not classified | Z-0174-2010 | Software design | Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or… |
| Sep 29, 2009 | Not classified | Z-0270-2010 | Software design | Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another… |
| Sep 29, 2009 | Not classified | Z-0271-2010 | Software design | Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K093612 (Siemens AG Medical Solutions, 2010) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K071114.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. syngo Imaging XS also supports storage and archiving of Structured DICOM Reports. In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer…
Read the full statement (98 words)
syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
It supports the physician in diagnosis and treatment planning.
syngo Imaging XS also supports storage and archiving of Structured DICOM Reports.
In a comprehensive imaging suite syngo Imaging XS integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows.
syngo Imaging XS optionally uses a variety of advanced postprocessing applications.
Note:
Web based image distribution is not intended for reporting.
syngo Imaging XS does not support the display of mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082430 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082430: Syngo Imaging XS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082430
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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