510(k) · Cleared
Recalled · Class II · 2017Syngo Imaging (Version V31)
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 Jul 3, 2008 as substantially equivalent to K071114 (Siemens AG Medical Solutions, 2007) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1997. 1 of the 191 devices in its family, counting itself, has a Class I recall. 177 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 3, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971684 (1997). 13 ancestors in all, the oldest K970852 (1997). 177 later devices descend from it, 1 citing it directly. 1 of the 191 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 2 generations backK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- 1 generation backK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- This deviceK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008
- Descendant · cites it directly · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- Descendant · 4 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 177 · See all- K092519Syngo.XSiemens AG Medical Solutions · 2009 · cites it directly176descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · 2 generations on54descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 4 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −4 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −3 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −2 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −1 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| 0 (this device) | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | — |
| +1 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| +4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 22 | 0 |
| 2021 | 8 | 0 |
| 2022 | 16 | 0 |
| 2023 | 17 | 0 |
| 2024 | 15 | 0 |
| 2025 | 15 | 1 |
| 2026 | 15 | 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.
1 device in this family has a Class I recall. 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…ification, is substantially equivalent to the following commercially available devices: Siemens syngo Imaging K071114 Siemens syngo MultiModality Workplace K061964 The syngo®Imaging described in this 510… | 2007 |
| * | K061964 | Syngo Multimodality WorkplaceSummary page 3…Siemens syngo Imaging K071114 Siemens syngo MultiModality Workplace K061964 The syngo®Imaging described in this 510(k) has the same intended use and similar technical characteristics as the devices liste… | 2006 |
| † | K042605 | Colongraphy Software Package with Extended Functionality | 2004 |
| † | K062673 | Modification to Syngo Inspace 4D | 2006 |
| † | K043122 | SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel Display | 2005 |
What descends from it? (177)
See all 1771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092519 | Syngo.X | 2009 | 176 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2017 | Class II | Z-0405-2018 | Software design | Siemens is releasing a letter to inform about potential data loss relevant to diagnosis. |
| Jan 18, 2016 | Class II | Z-1349-2016 | Software design | To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging. |
| Oct 28, 2015 | Class II | Z-0319-2016 | Software change control | To provide supplementary information regarding the release of the syngo Imaging Software Version VB36D_HF02. The software provides improvements for all syngo Imaging installations running on the software Version VB36D. |
| Jun 11, 2015 | Class II | Z-1972-2015 | Software design | During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size. |
| Jun 1, 2009 | Not classified | Z-1650-2009 | Software design | Risk of misinterpretation of patient response to treatment: Date displayed may be incorrect. Filtering based on examination date may lead to an incorrect list of examinations. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 13 ancestors have a recall of any class.
- Of its descendants, K092519 (Siemens AG Medical Solutions, 2009) has gone furthest, with 176 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 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. For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only…
Read the full statement (106 words)
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.
For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used.
Also only monitors which received FDA clearance for mammography must be used.
syngo®Imaging also supports storage and archiving of DICOM Structured 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/K081734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081734: Syngo Imaging (Version V31).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081734
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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