510(k) · Cleared
Clearedsyngo Dynamics Version VA30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare GmbH · LLZ System, Image Processing, Radiological
Cleared on Jun 1, 2017 as substantially equivalent to K123922 (Siemens Medical Solutions USA, Inc., 2013) after a 52-day review. Its family tree reaches back 9 generations to 1984. 4 later devices descend from it.
- Decided
- Jun 1, 2017
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K842308 (1984). 31 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 5 generations between
- 3 generations backK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
- 2 generations backK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013
- This deviceK171053 syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017
- Descendant · cites it directly · 3 of its ownK220832 syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK222428 Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK242551 syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025
- Descendant · 4 generations on · 0 of its ownK253689 syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026
Show all 9 generations
- Root · 9 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 8 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 7 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 6 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 5 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 4 generations backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- 3 generations backK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
- 2 generations backK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- 1 generation backK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013
- This deviceK171053 syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017
Most influential descendants
Showing 4 of 4 · See all- K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022 · cites it directly3descendants
- K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022 · 2 generations on2descendants
- K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025 · 3 generations on1descendant
- K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −8 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −7 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −6 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −5 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −4 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| −3 | K081018 | Syngo Dynamics Version 7.0 | Siemens Medical Solutions | 2008 | — |
| −2 | K102150 | Syngo Dynamics, Version 9.0 | Siemens Medical Solutions USA, Inc. | 2010 | 7 |
| −1 | K123922 | Syngo Dynamics | Siemens Medical Solutions USA, Inc. | 2013 | — |
| 0 (this device) | K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017 | — |
| +1 | K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +2 | K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +3 | K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 2025 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K123922 | Syngo DynamicsSummary page 4…Product Code: LLZ 4. Legally Marketed Predicate Device Trade Name: syngo Dynamics 510(k) Clearance: K123922 ©Siemens Healthcare GmbH, 2017 40 Liberty Boulevard Tel.: +1‐888‐826‐9702… | 2013 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220832 | syngo Dynamics (Version VA40E) | 2022 | 3 |
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 33 years and passes through 8 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 31 ancestors have a recall of any class.
- Of its descendants, K220832 (Siemens Medical Solutions USA, Inc., 2022) has gone furthest, with 3 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. 2017, 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 Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.
As a Cardiology PACS and information system, syngo Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments.
syngo Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171053: syngo Dynamics Version VA30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171053
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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