510(k) · Cleared
Recalled · Class II · 2018Syngo.Plaza VB10A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Healthcare · LLZ System, Image Processing, Radiological
Cleared on Dec 9, 2013 as substantially equivalent to K101666 (Siemens AG Medical Solutions, 2010) after a 119-day review. Its family tree reaches back 8 generations to 1997. 8 later devices descend from it. It has been recalled 11 times.
- Decided
- Dec 9, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 8 generations to K971684 (1997). 25 ancestors in all, the oldest K945188 (1995). 8 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 3 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 2 generations backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- 1 generation backK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010 · Recalled
- This deviceK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013
- Descendant · cites it directly · 6 of its ownK142750 JiveXVisus Technology Transfer GmbH · 2015
- Descendant · 2 generations on · 4 of its ownK162008 JiveXVisus Technology Transfer GmbH · 2016
- Descendant · 3 generations on · 3 of its ownK181964 JiveXVisus Health IT GmbH · 2018
- Descendant · 4 generations on · 2 of its ownK200703 JiveXVisus Health IT GmbH · 2020
- Descendant · 5 generations on · 1 of its ownK212321 JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142750JiveXVisus Technology Transfer GmbH · 2015 · cites it directly6descendants
- K162008JiveXVisus Technology Transfer GmbH · 2016 · 2 generations on4descendants
- K181964JiveXVisus Health IT GmbH · 2018 · 3 generations on3descendants
- K200703JiveXVisus Health IT GmbH · 2020 · 4 generations on2descendants
- K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −3 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −2 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| −1 | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | 3 |
| 0 (this device) | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | — |
| +1 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| +2 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| +3 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
| +4 | K200703 | JiveX | Visus Health IT GmbH | 2020 | — |
| +5 | K212321 | JiveX (Model Number / Release: 5.3) | Visus Health IT GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K101666 | Syngo. Plaza VA20ASummary page 2…dates / upgrades are offered based on service contracts and fulfilled by trained service technicians. This is also applicable for the predicate device syngo.plaza VA2OA (K 101666). 510(k) for svngodW.plaza July 30. 2013 Page K 3 v ) 28eg £10T 0€ AIn… | 2010 |
What descends from it? (8)
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 |
|---|---|---|---|---|
| Feb 20, 2018 | Class II | Z-1700-2018 | Software design | Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. |
| Feb 20, 2018 | Class II | Z-1699-2018 | Software design | Software upgrade to correct format of study dates and issues with Legacy Presentation States (annotations) in order to prevent potential patient misdiagnosis. |
| Aug 23, 2017 | Class II | Z-0524-2018 | Software design | When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The… |
| Aug 18, 2017 | Class II | Z-0495-2018 | Software design | Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions… |
| May 22, 2017 | Class II | Z-0168-2018 | Software design | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of… |
| Sep 6, 2016 | Class II | Z-2892-2016 | Software design | Software upgrade to eliminate several issues |
| Aug 2, 2016 | Class II | Z-2794-2016 | 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… |
| 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… |
| 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… |
The 5 latest of 11 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 16 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 25 ancestors have a recall of any class.
- Of its descendants, K142750 (Visus Technology Transfer GmbH, 2015) has gone furthest, with 6 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. 2013, 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 Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including maninographic images. It supports the physician in diagnosis and treatment planning. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and…
Read the full statement (114 words)
syngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including maninographic images.
It supports the physician in diagnosis and treatment planning.
For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images and only preprocessed DICOM "For Presentation" images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography must be used.
syngo.plaza also supports DICOM Structured Reports.
In a comprehensive imaging suite, syngo.plaza integrates Hospital / Radiology Information Systems (HIS / RIS) to enable customer specific workflows.
s)7igo.plaza optionally uses a variety of advanced postprocessing applications.
Note:
Web-based image distribution is not intended for reporting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132532: Syngo.Plaza VB10A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132532
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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