510(k) · Cleared
Recalled · Class II · 2012Syngo. Plaza VA20A
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 Aug 10, 2010 as substantially equivalent to K093612 (Siemens AG Medical Solutions, 2010) and 2 other predicates after a 57-day review. Its family tree reaches back 7 generations to 1997. 9 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 10, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 7 generations to K971684 (1997). 24 ancestors in all, the oldest K945188 (1995). 9 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 5 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- 2 generations backK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- 1 generation backK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- This deviceK101666 Syngo. Plaza VA20ASiemens AG Medical Solutions · 2010
- Descendant · cites it directly · 8 of its ownK132532 Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK142750 JiveXVisus Technology Transfer GmbH · 2015
- Descendant · 3 generations on · 4 of its ownK162008 JiveXVisus Technology Transfer GmbH · 2016
- Descendant · 4 generations on · 3 of its ownK181964 JiveXVisus Health IT GmbH · 2018
- Descendant · 5 generations on · 2 of its ownK200703 JiveXVisus Health IT GmbH · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K132532Syngo.Plaza VB10ASiemens AG Healthcare · 2013 · cites it directly8descendants
- K142750JiveXVisus Technology Transfer GmbH · 2015 · 2 generations on6descendants
- K162008JiveXVisus Technology Transfer GmbH · 2016 · 3 generations on4descendants
- K181964JiveXVisus Health IT GmbH · 2018 · 4 generations on3descendants
- K200703JiveXVisus Health IT GmbH · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −6 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −5 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −4 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| −2 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| −1 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| 0 (this device) | K101666 | Syngo. Plaza VA20A | Siemens AG Medical Solutions | 2010 | — |
| +1 | K132532 | Syngo.Plaza VB10A | Siemens AG Healthcare | 2013 | 11 |
| +2 | K142750 | JiveX | Visus Technology Transfer GmbH | 2015 | — |
| +3 | K162008 | JiveX | Visus Technology Transfer GmbH | 2016 | — |
| +4 | K181964 | JiveX | Visus Health IT GmbH | 2018 | — |
| +5 | K200703 | JiveX | Visus Health IT GmbH | 2020 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K093612 | Syngo.PlazaSummary page 2…ens service engineers. The backend communication and storage solution is based in Windows 2008 operating systems as described in the predicate devices syngo.plaza VA1OA (093612) and syngo.x (1(092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA 1OA (0936… | 2010 |
| * | K071114 | Syngo Imaging (Version V30) | 2007 |
| * | K092519 | Syngo.XSummary page 2…ngo.plaza VA1OA (093612) and syngo.x (1(092519). The clients are based on Windows XP as also described in the predicate devices syngo.plaza VA 1OA (0936 12) and.syngo.x (K0925 19) The syngo.plaza will be marketed as a software only solution for the end-user (with recommended hardware requirements). It wil… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132532 | Syngo.Plaza VB10A | 2013 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2012 | Class II | Z-2275-2012 | Software design | There is a potential malfunction in which a miscalculation occurs for images with pixel depth values greater that 12 bit in certain functions. |
| Feb 24, 2012 | Class II | Z-2078-2012 | Software design | Siemens became aware of a potential malfunction when using syngo.plaza with software version VA20C_HF01. For datasets with distance measurements it can happen, that all images are not loaded to Viewer but no error message is displayed to… |
| May 1, 2011 | Not classified | Z-0827-2012 | Software design | The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.plaza version VA20 with Server Farm setup integrated to a RIS. Sporadically it can happen that certain Patient IDs in the database… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 24 ancestors have a recall of any class.
- Of its descendants, K132532 (Siemens AG Healthcare, 2013) has gone furthest, with 8 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?
svyngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic 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 (111 words)
svyngo.plaza is a Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive digital medical images, including mammographic 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.
.syngo.plaza optionally uses a variety of advanced postprocessing applications.
Note:
Web-based image distribution is not intended for reporting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101666: Syngo. Plaza VA20A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101666
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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