510(k) · Cleared
ClearedScenium 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Molecular Imaging, Ltd. · KPS System, Tomography, Computed, Emission
Cleared on Jun 30, 2006 as substantially equivalent to K042863 (Siemens Molecular Imaging, Ltd., 2004) and 2 other predicates after a 25-day review. Its family tree reaches back 5 generations to 2001. 91 later devices descend from it.
- Decided
- Jun 30, 2006
- Review
- 25 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K010641 (2001). 12 ancestors in all, the oldest K914350 (1991). 91 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 4 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 3 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 2 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- 1 generation backK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- This deviceK061545 Scenium 1.1Siemens Molecular Imaging, Ltd. · 2006
- Descendant · cites it directly · 90 of its ownK121074 Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012
- Descendant · 2 generations on · 79 of its ownK123528 SceniumSiemens Medical Solutions USA, Inc. · 2012
- Descendant · 3 generations on · 77 of its ownK130884 Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
- Descendant · 4 generations on · 60 of its ownK153355 Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016
- Descendant · 5 generations on · 53 of its ownK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
Showing 5 of 91 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 91 · See all- K121074Scenium 2.0Siemens Medical Solutions USA, Inc. · 2012 · cites it directly90descendants
- K123528SceniumSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on79descendants
- K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013 · 3 generations on77descendants
- K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare · 2016 · 4 generations on60descendants
- K182624MIM - MRT DosimetryMim Software, Inc. · 2018 · 5 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −4 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −3 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −2 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| −1 | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| 0 (this device) | K061545 | Scenium 1.1 | Siemens Molecular Imaging, Ltd. | 2006 | — |
| +1 | K121074 | Scenium 2.0 | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +2 | K123528 | Scenium | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +3 | K130884 | Xeleris 3.1 Processing and Review Workstation | Ge Medical Systems F.I. Haifa | 2013 | — |
| +4 | K153355 | Xeleris 4.0 Processing and Review Workstation | GE Healthcare | 2016 | — |
| +5 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 11 | 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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 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 |
|---|---|---|---|
| * | K042863 | SceniumSummary page 2…claimed Device Manufacturer 510(k) Number Scenium Siemens Molecular K042863 Imaging Ltd (formerly Mirada Solutions Lt… | 2004 |
| * | K041022 | Neuroq - Pet DPSummary page 2…Imaging Ltd (formerly Mirada Solutions Ltd) Syntermed NeuroQ TM Syntermed Inc K041022 Segami NeuroGam TM on Segami Corporation K043441 Mirage Tm Device Description: Scenium 1.1 di… | 2004 |
| * | K043441 | Mirage, Release 5.5Summary page 2…Solutions Ltd) Syntermed NeuroQ TM Syntermed Inc K041022 Segami NeuroGam TM on Segami Corporation K043441 Mirage Tm Device Description: Scenium 1.1 display and analysis software enables visualization and appropriate rendering of mu… | 2005 |
What descends from it? (91)
See all 911 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121074 | Scenium 2.0 | 2012 | 90 |
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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K121074 (Siemens Medical Solutions USA, Inc., 2012) has gone furthest, with 90 descendants of its own.
- 2 other devices also cite its predicate K042863.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
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 workstations 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 facilitating comparison with existing scans derived from FDG-PET and SPECT studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061545 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061545: Scenium 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061545
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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