510(k) · Cleared
ClearedSyngo MBF
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 Apr 6, 2011 as substantially equivalent to K083327 (Siemens Medical Solutions USA, Inc., 2009) after a 43-day review. Its family tree reaches back 6 generations to 1991. 6 later devices descend from it.
- Decided
- Apr 6, 2011
- Review
- 43 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 14 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 4 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 3 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 2 generations backK063762 Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2007
- 1 generation backK083327 Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc. · 2009
- This deviceK110494 Syngo MBFSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 5 of its ownK201195 syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 4 of its ownK211459 syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK232000 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2023
- Descendant · 4 generations on · 2 of its ownK242275 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 5 generations on · 1 of its ownK251528 syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. · 2020 · cites it directly5descendants
- K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc. · 2021 · 2 generations on4descendants
- K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2023 · 3 generations on3descendants
- K242275syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2024 · 4 generations on2descendants
- K251528syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −4 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −3 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −2 | K063762 | Syngo Circulation Software Package with Extended Functionality | Siemens AG Medical Solutions | 2007 | — |
| −1 | K083327 | Syngocirculation Dynamicpet, Version 1.0 | Siemens Medical Solutions USA, Inc. | 2009 | — |
| 0 (this device) | K110494 | Syngo MBF | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K201195 | syngo.via MI Workflows, syngo MBF | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K211459 | syngo.via MI WorkFlows, Scenium, syngo MBF | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +3 | K232000 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2023 | — |
| +4 | K242275 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +5 | K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | 2025 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K083327 | Syngocirculation Dynamicpet, Version 1.0Summary page 2…ce is claimed Device Manufacturer 510(k) Number SyngoCirculation Siemens Medical Solutions USA, Inc. K(083327 Dynamic PET 1.0 Device Description: syngo MBF isa software only product intended for visualization, assessment and quantifica… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201195 | syngo.via MI Workflows, syngo MBF | 2020 | 5 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K201195 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K083327.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 syngo MBF 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…
Read the full statement (134 words)
Siemens syngo MBF 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.
Siemens syngo MBF 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/K110494 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110494: Syngo MBF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110494
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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