510(k) · Cleared
Clearedsyngo Application Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 16, 2016 as substantially equivalent to K153346 (Siemens Medical Solutions USA, Inc., 2016) after a 65-day review. Its family tree reaches back 5 generations to 2001. 35 later devices descend from it.
- Decided
- Nov 16, 2016
- Review
- 65 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010938 (2001). 35 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 4 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 3 generations backK042995 X-LeonardoSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK143319 Syngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc. · 2015 · Recalled
- 1 generation backK153346 syngo Application Software VD11Siemens Medical Solutions USA, Inc. · 2016
- This deviceK162541 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2016
- Descendant · cites it directly · 23 of its ownK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 10 of its ownK190768 ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 10 of its ownK181550 Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 10 of its ownK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- Descendant · cites it directly · 10 of its ownK163285 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2017
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · cites it directly23descendants
- K190768ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on10descendants
- K181550Cios SpinSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on10descendants
- K181560Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · 2 generations on10descendants
- K163285syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2017 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −4 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −3 | K042995 | X-Leonardo | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | 2015 | 2 |
| −1 | K153346 | syngo Application Software VD11 | Siemens Medical Solutions USA, Inc. | 2016 | — |
| 0 (this device) | K162541 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +1 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| +2 | K190768 | ARTIS icono | Siemens Medical Solutions USA, Inc. | 2019 | 4 |
| +2 | K181550 | Cios Spin | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +2 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| +1 | K163285 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K153346 | syngo Application Software VD11Summary page 5…ion Software K162541 AI Response 4. Legally Marketed Predicate Device Trade Name: syngo Application Software 510(k) Clearance K153346 Clearance Date March 4, 2016 Classification Name: Picture Archiving and Communications System… | 2016 |
What descends from it? (35)
See all 352 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K163286 (Siemens Medical Solution USA, Inc., 2017) has gone furthest, with 23 descendants of its own.
- 1 other device also cites its predicate K153346.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and…
Read the full statement (202 words)
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.
The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation, It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.
The syngo Application Software can also be combined with fluoroscopy systems or Radiographic systems.
The syngo Application Software can be configured with a varicty of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options,
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.
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/K162541 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162541: syngo Application Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162541
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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