510(k) · Cleared
Clearedsyngo Dynamics (VA41F)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · QIH Automated Radiological Image Processing Software
Cleared on Apr 10, 2026 as substantially equivalent to K242551 (Siemens Healthcare GmbH, 2025) after a 140-day review. Its family tree reaches back 13 generations to 1984.
- Decided
- Apr 10, 2026
- Review
- 140 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K842308 (1984). 35 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 9 generations between
- 3 generations backK220832 syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022
- 2 generations backK222428 Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022
- 1 generation backK242551 syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025
- This deviceK253689 syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026
Show all 13 generations
- Root · 13 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 12 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 11 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 10 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 9 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 8 generations backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- 7 generations backK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
- 6 generations backK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- 5 generations backK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013
- 4 generations backK171053 syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017
- 3 generations backK220832 syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022
- 2 generations backK222428 Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022
- 1 generation backK242551 syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025
- This deviceK253689 syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −12 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −11 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −10 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −9 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −8 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| −7 | K081018 | Syngo Dynamics Version 7.0 | Siemens Medical Solutions | 2008 | — |
| −6 | K102150 | Syngo Dynamics, Version 9.0 | Siemens Medical Solutions USA, Inc. | 2010 | 7 |
| −5 | K123922 | Syngo Dynamics | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −4 | K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017 | — |
| −3 | K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −2 | K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| −1 | K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 2025 | — |
| 0 (this device) | K253689 | syngo Dynamics (VA41F) | Siemens Healthcare GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 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 |
|---|---|---|---|
| * | K242551 | syngo Dynamics (Version VA41D)Summary page 5…21CFR § 807.92(a)(3) Predicate Device Device Trade Name syngo Dynamics (Version VA41D) 510(k) Number K242551 Product Code QIH This predicate has not been subject to a design-related recall. Siemens Healthineers… | 2025 |
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 42 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 35 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?
syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.
syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within healthcare institution’s network.
syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253689: syngo Dynamics (VA41F).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253689
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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