510(k) · Cleared
ClearedScenium
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 Dec 20, 2012 as substantially equivalent to K121074 (Siemens Medical Solutions USA, Inc., 2012) and 2 other predicates after a 34-day review. Its family tree reaches back 7 generations to 2001. 79 later devices descend from it.
- Decided
- Dec 20, 2012
- Review
- 34 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K010641 (2001). 16 ancestors in all, the oldest K914350 (1991). 79 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 6 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 4 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 3 generations backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- 2 generations backK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- 1 generation backK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- This deviceK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · 2 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- Descendant · 3 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- Descendant · 4 generations on · 30 of its ownK191928 AccuContourXiamen Manteia Technology, Ltd. · 2020
- Descendant · cites it directly · 15 of its ownK140269 Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · cites it directly77descendants
- K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 2 generations on60descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 3 generations on53descendants
- K191928AccuContourXiamen Manteia Technology, Ltd. · 2020 · 4 generations on30descendants
- K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB · 2014 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −6 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −5 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −4 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −3 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| −2 | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| −1 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| 0 (this device) | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +2 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| +3 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| +4 | K191928 | AccuContour | Xiamen Manteia Technology, Ltd. | 2020 | — |
| +1 | K140269 | Hermes Medical Imaging Suite V5.4 | Hermes Medical Solutions AB | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 9 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121074 | Scenium 2.0Summary page 2…ch Equivalence isclaimed Device Manufacturer 51 0(k) Number Scenium 2.0 Siemens Medical Solutions USA, Inc K1 21074 NeuroTrans3D Segami Corporation K043441 Brass Hermes Medical Solutions… | 2012 |
| * | K043441 | Mirage, Release 5.5Summary page 2…51 0(k) Number Scenium 2.0 Siemens Medical Solutions USA, Inc K1 21074 NeuroTrans3D Segami Corporation K043441 Brass Hermes Medical Solutions K(021656 Device Description: Scenium 3.0 display and analysis… | 2005 |
| * | K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4Summary page 2…Solutions USA, Inc K1 21074 NeuroTrans3D Segami Corporation K043441 Brass Hermes Medical Solutions K(021656 Device Description: Scenium 3.0 display and analysis software enables visualization and appropriate rendering of multimodality… | 2002 |
What descends from it? (79)
See all 793 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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K130884 (Ge Medical Systems F.I. Haifa, 2013) has gone furthest, with 77 descendants of its own.
- 2 other devices also cite its predicate K121074.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The Scenium display and analysis software has been developed to aid the Clinician in the
assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workplaces and is organized as a series of
workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis
through quantification of mean pixel values located within standard regions of interest. It
facilitates comparison with existing scans derived from FOG-PET, amyloid-PET, and SPECT
studies and calculation of uptake ratios between regions of interest.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123528 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123528: Scenium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123528
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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