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. · QIH Automated Radiological Image Processing Software
Cleared on Apr 29, 2026 as substantially equivalent to K241569 (Siemens Medical Solutions USA, Inc., 2024) after a 127-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Apr 29, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K010938 (2001). No later device cites it as a predicate yet.
- Root · 13 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 9 generations between
- 3 generations backK220433 syngo Application Software (VE21)Siemens Medical Solution USA, Inc. · 2022
- 2 generations backK230955 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2023
- 1 generation backK241569 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2024
- This deviceK254184 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2026
Show all 13 generations
- Root · 13 generations backK010938 Syngo Multimodality WorkstationSiemens Medical Solutions USA, Inc. · 2001 · Recalled
- 12 generations backK040970 LeonardoSiemens Medical Systems, Inc. · 2004 · Recalled
- 11 generations backK042995 X-LeonardoSiemens Medical Solutions USA, Inc. · 2004
- 10 generations backK143319 Syngo X-workplace SW VD10Siemens Medi Cal Solutions, Inc. · 2015 · Recalled
- 9 generations backK153346 syngo Application Software VD11Siemens Medical Solutions USA, Inc. · 2016
- 8 generations backK162541 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2016
- 7 generations backK163285 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2017
- 6 generations backK170747 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2017
- 5 generations backK173611 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2018
- 4 generations backK190780 syngo Application SoftwareSiemens Medical Solution USA, Inc. · 2019
- 3 generations backK220433 syngo Application Software (VE21)Siemens Medical Solution USA, Inc. · 2022
- 2 generations backK230955 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2023
- 1 generation backK241569 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2024
- This deviceK254184 syngo Application SoftwareSiemens Medical Solutions USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010938 | Syngo Multimodality Workstation | Siemens Medical Solutions USA, Inc. | 2001 | 5 |
| −12 | K040970 | Leonardo | Siemens Medical Systems, Inc. | 2004 | 1 |
| −11 | K042995 | X-Leonardo | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −10 | K143319 | Syngo X-workplace SW VD10 | Siemens Medi Cal Solutions, Inc. | 2015 | 2 |
| −9 | K153346 | syngo Application Software VD11 | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −8 | K162541 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −7 | K163285 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2017 | — |
| −6 | K170747 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2017 | — |
| −5 | K173611 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −4 | K190780 | syngo Application Software | Siemens Medical Solution USA, Inc. | 2019 | — |
| −3 | K220433 | syngo Application Software (VE21) | Siemens Medical Solution USA, Inc. | 2022 | — |
| −2 | K230955 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2023 | — |
| −1 | K241569 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2024 | — |
| 0 (this device) | K254184 | syngo Application Software | Siemens Medical Solutions USA, Inc. | 2026 | — |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K241569 | syngo Application SoftwareSummary page 5…uct Code: QIH 4. Legally Marketed Predicate Device Trade Name: syngo Application Software 510(k) Clearance K241569 Clearance Date 10/11/2024… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 3 of the 13 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3Dvisualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting…
Read the full statement (201 words)
The syngo Application Software is a medical software for real-time viewing, image manipulation, 3Dvisualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and postprocessing and for viewing and postprocessing during interventional procedures.
The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, 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 Healthineers 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 variety 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 postprocessing techniques and OEM options.
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254184 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254184: 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/K254184
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026