510(k) · Cleared
Recalled · Class II · 2017Syngo.Plaza
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 Mar 4, 2010 as substantially equivalent to K082430 (Siemens AG Medical Solutions, 2008) after a 101-day review. Its family tree reaches back 6 generations to 1995. 10 later devices descend from it. It has been recalled 16 times.
- Decided
- Mar 4, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 16
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945188 (1995). 8 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 5 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 4 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 3 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 2 generations backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- 1 generation backK082430 Syngo Imaging XSSiemens AG Medical Solutions · 2008 · Recalled
- This deviceK093612 Syngo.PlazaSiemens AG Medical Solutions · 2010
- Descendant · cites it directly · 9 of its ownK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK142750 JiveXVisus Technology Transfer GmbH · 2015
- Descendant · 4 generations on · 4 of its ownK162008 JiveXVisus Technology Transfer GmbH · 2016
- Descendant · 5 generations on · 3 of its ownK181964 JiveXVisus Health IT GmbH · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K101666Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · cites it directly9descendants
- K132532Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · 2 generations on8descendants
- K142750JiveXVisus Technology Transfer GmbH · 2015 · 3 generations on6descendants
- K162008JiveXVisus Technology Transfer GmbH · 2016 · 4 generations on4descendants
- K181964JiveXVisus Health IT GmbH · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −5 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −4 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −3 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −2 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| −1 | K082430 | Syngo Imaging XS | Siemens AG Medical Solutions | 2008 | 12 |
| 0 (this device) | K093612 | Syngo.Plaza | Siemens AG Medical Solutions | 2010 | — |
| +1 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| +2 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| +3 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| +4 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| +5 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
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 | 1 | 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? (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 |
|---|---|---|---|
| * | K082430 | Syngo Imaging XSSummary page 3…otification, is substantially equivalent to the following commercially available device: Siemens .syngo Imaging XS V70 K082430 The syngo.plaza described in this 510(k) has the same intended use and similar technical characteristics as the device listed a… | 2008 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101666 | Syngo. Plaza VA20A | 2010 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2017 | Class II | Z-1533-2017 | Software design | Software updates |
| Jan 11, 2017 | Class II | Z-1116-2017 | Under Investigation by firm | Software update for improvements and to resolve several issues |
| Sep 6, 2016 | Class II | Z-2891-2016 | Software design | Software upgrade to eliminate several issues |
| Aug 2, 2016 | Class II | Z-2793-2016 | Error in labeling | Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows on some DICOM images on area, distance or perimeter values. This suffix stands for on projection and indicates that a shown measurement… |
| May 9, 2016 | Class II | Z-2088-2016 | Software design | Software error in previous software versions in which two references for the same image may exist in the database. |
| Dec 22, 2015 | Class II | Z-0862-2016 | Software design | Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region… |
| Jul 6, 2015 | Class II | Z-2719-2015 | Software design | Potential issue leading to data loss and patient data mix-up |
| Feb 18, 2015 | Class II | Z-1354-2015 | Software design | Possibly incomplete archived studies during pre-fetch. In a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived. |
| Jan 13, 2015 | Class II | Z-1027-2015 | Software Manufacturing/Software Deployment | In case of a system crash, images may not be written to the hard disk and this may result in inconsistencies in the database. In case of a system crash (e.g. blue screen, power outage) images may not be written from cache to the hard disk… |
| 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… |
| Mar 4, 2013 | Class II | Z-1975-2013 | Software design | Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. In some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be… |
| Jun 20, 2012 | Class II | Z-0465-2013 | Software design | Firm has become aware of an unintended behavior when using syngo.plaza and issued an Update Instruction. The Update Instruction SY050/12/S provides a software update and addresses the following issues: - Patient Rename messages for the… |
| Jun 6, 2012 | Class II | Z-0048-2013 | Software design | Siemens became aware of an unintended behavior when using syngo.plaza. In syngo.plaza within the online "Short Time Storage" (STS), some studies are marked with an archived icon, however, the entry in the Archive Database referring to the… |
| Jan 20, 2012 | Not classified | Z-1127-2012 | Software design | There is a potential malfunction when using syngo.plaza VA20B_HF04 with USB dongle and archive license. In syngo.plaza VA20B_HF04, there is a scenario where data in Short-Term Storage (STS) could reaming unprotected and not archived. this… |
| Sep 21, 2011 | Not classified | Z-0522-2012 | Software design | Potential malfunction when using syngo.plaza. On syngo.plaza workplaces large studies can be loaded into the viewer if transferred from a DICOM node or imported even while image transfer is not yet completed. In these situations more… |
| Aug 8, 2011 | Class II | Z-0271-2014 | Software design | The firm became aware of an unintended behavior when using the syngo.plaza. The "Rename" functionality can cause an unintended patient merge if the patient is sent to another system. This issue affects customers who transfer patient data… |
The 5 latest of 16 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 15 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K101666 (Siemens AG Medical Solutions, 2010) has gone furthest, with 9 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. 2010, 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.plaza is a Picture Archiving and Conmunication 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. plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo. plaza integrates Hospital/Radiology Informhation Systems (HIS/RIS) to enable customer specific…
Read the full statement (93 words)
syngo.plaza is a Picture Archiving and Conmunication 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. plaza also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo. plaza integrates Hospital/Radiology Informhation Systems (HIS/RIS) to enable customer specific workflows. syngo. plaza optionally uses a variety of advanced postprocessing applications. Note: Web-based image dihtribution is not intended for reporting. In the U.S.A., syngo.plaza is not intended for the reporting of digital mammography images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093612 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093612: Syngo.Plaza.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093612
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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