510(k) · Cleared
ClearedSyngocirculation Dynamicpet, Version 1.0
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 May 18, 2009 as substantially equivalent to K080770 (Cardiovascular Imaging Technologies, LLC, 2008) and 1 other predicate after a 187-day review. Its family tree reaches back 5 generations to 1991. 20 later devices descend from it.
- Decided
- May 18, 2009
- Review
- 187 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 13 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 3 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 2 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- This deviceK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- Descendant · cites it directly · 12 of its ownK101279 CORRIDOR4DM V2010 Model: V2010Invia · 2010
- Descendant · cites it directly · 9 of its ownK113754 CFR QuantUniversity of Texas Medical School AT Houston · 2012
- Descendant · 2 generations on · 6 of its ownK143664 HeartSeeUniversity of Texas Medical School AT Houston · 2015
- Descendant · cites it directly · 6 of its ownK110494 Syngo MBFSiemens Medical Solutions USA, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK201195 syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K101279CORRIDOR4DM V2010 Model: V2010Invia · 2010 · cites it directly12descendants
- K113754CFR QuantUniversity of Texas Medical School AT Houston · 2012 · cites it directly9descendants
- K143664HeartSeeUniversity of Texas Medical School AT Houston · 2015 · 2 generations on6descendants
- K110494Syngo MBFSiemens Medical Solutions USA, Inc. · 2011 · cites it directly6descendants
- K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −3 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −2 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| 0 (this device) | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +1 | K101279 | CORRIDOR4DM V2010 Model: V2010 | Invia | 2010 | — |
| +1 | K113754 | CFR Quant | University of Texas Medical School AT Houston | 2012 | — |
| +2 | K143664 | HeartSee | University of Texas Medical School AT Houston | 2015 | — |
| +1 | K110494 | Syngo MBF | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +2 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080770 | Imagenmd with ImagenqSummary page 1…Equivalence is claimed Device Manufacturer 510(k) Number ImagenMDTMvwith lmagenQ Cardiovascular Imaging K080770 TM Technologies Syngo® Circulation Siemens AG Medical K(063762,K1(5202… | 2008 |
| * | K063762 | Syngo Circulation Software Package with Extended FunctionalitySummary page 1…agenQ Cardiovascular Imaging K080770 TM Technologies Syngo® Circulation Siemens AG Medical K(063762,K1(52029 Solutions QRMIOO97-T-01… | 2007 |
| Kept off the family tree | K052029 | FDA’s K052029 is Syngo Circulation Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
What descends from it? (20)
See all 203 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 18 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K101279 (Invia, 2010) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K080770.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Siemens syngoCirculation DynamicPET is a software product intended for visualization, assessment and quantification of PET images.
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083327 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083327: Syngocirculation Dynamicpet, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083327
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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