510(k) · Cleared
Recalled · Class II · 2016Syngo Imaging (Version V30)
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 May 22, 2007 after a 32-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 1 of the 182 devices in its family, counting itself, has a Class I recall. 181 later devices descend from it. It has been recalled 7 times.
- Decided
- May 22, 2007
- Review
- 32 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 7
- Predicates
- 2
181 later devices descend from it, 4 citing it directly. 1 of the 182 devices in this family, counting this one, has a Class I recall.
- This deviceK071114 Syngo Imaging (Version V30)Siemens AG Medical Solutions · 2007
- Descendant · cites it directly · 177 of its ownK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · Recalled
- Descendant · 2 generations on · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- Descendant · 3 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 3 generations on · 54 of its ownK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 181 · See all- K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · cites it directly177descendants
- K092519Syngo.XSiemens AG Medical Solutions · 2009 · 2 generations on176descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 3 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
- K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010 · 3 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071114 | Syngo Imaging (Version V30) | Siemens AG Medical Solutions | 2007 | — |
| +1 | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | 5 |
| +2 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| +3 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +3 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K052409 | FDA’s K052409 is Silgimix Alginate Replacement Impression Material Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| Kept off the family tree | K021161 | FDA’s K021161 is TSO3 Ozone Chemical Indicator Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
What descends from it? (181)
See all 1814 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Jan 12, 2009 | Not classified | Z-1235-2009 | Software design | Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability… |
| Aug 22, 2008 | Not classified | Z-0102-2009 | Software design | Image may not be visible after merge. |
| Mar 10, 2008 | Not classified | Z-1643-2008 | Software design | The firm discovered a problem where the selected patient images on the device may display an additional image from another patient or study. |
| Nov 27, 2007 | Not classified | Z-0732-2008 | Software design | Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high) |
The 5 latest of 7 recalls; the web page lists all.
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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K081734 (Siemens AG Medical Solutions, 2008) has gone furthest, with 177 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. 2007, 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 (109 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 approval for mammography must be used.
,syngo®Imaging also supports storage and archiving of DJCOM 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/K071114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071114: Syngo Imaging (Version V30).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071114
Report an extraction error
Are you the manufacturer?
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