510(k) · Cleared
ClearedSyngo Dynamics
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 Jan 16, 2013 as substantially equivalent to K102150 (Siemens Medical Solutions USA, Inc., 2010) after a 27-day review. Its family tree reaches back 8 generations to 1984. 5 later devices descend from it.
- Decided
- Jan 16, 2013
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K842308 (1984). 30 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 7 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 6 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 5 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 4 generations backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- 3 generations backK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
- 2 generations backK081018 Syngo Dynamics Version 7.0Siemens Medical Solutions · 2008
- 1 generation backK102150 Syngo Dynamics, Version 9.0Siemens Medical Solutions USA, Inc. · 2010 · Recalled
- This deviceK123922 Syngo DynamicsSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK171053 syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017
- Descendant · 2 generations on · 3 of its ownK220832 syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK222428 Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK242551 syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025
- Descendant · 5 generations on · 0 of its ownK253689 syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026
Most influential descendants
Showing 5 of 5 · See all- K171053syngo Dynamics Version VA30Siemens Healthcare GmbH · 2017 · cites it directly4descendants
- K220832syngo Dynamics (Version VA40E)Siemens Medical Solutions USA, Inc. · 2022 · 2 generations on3descendants
- K222428Syngo Dynamics (Version VA40F)Siemens Medical Solutions USA, Inc. · 2022 · 3 generations on2descendants
- K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH · 2025 · 4 generations on1descendant
- K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −7 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −6 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −5 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −4 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| −3 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
| −2 | K081018 | Syngo Dynamics Version 7.0 | Siemens Medical Solutions | 2008 | — |
| −1 | K102150 | Syngo Dynamics, Version 9.0 | Siemens Medical Solutions USA, Inc. | 2010 | 7 |
| 0 (this device) | K123922 | Syngo Dynamics | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K171053 | syngo Dynamics Version VA30 | Siemens Healthcare GmbH | 2017 | — |
| +2 | K220832 | syngo Dynamics (Version VA40E) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +3 | K222428 | Syngo Dynamics (Version VA40F) | Siemens Medical Solutions USA, Inc. | 2022 | — |
| +4 | K242551 | syngo Dynamics (Version VA41D) | Siemens Healthcare GmbH | 2025 | — |
| +5 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K102150 | Syngo Dynamics, Version 9.0Summary page 6…Manufacturer Predicate Device Name NumbCerc Siemens Medical Solutions syngo Dynamics Version 9.0 K102150 USA, Inc. _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ The potential hazards of… | 2010 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171053 | syngo Dynamics Version VA30 | 2017 | 4 |
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 29 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 11 of the 30 ancestors have a recall of any class.
- Of its descendants, K171053 (Siemens Healthcare GmbH, 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K102150.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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/K123922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123922: Syngo Dynamics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123922
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