510(k) · Cleared
ClearedScenium
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 Dec 15, 2004 as substantially equivalent to K041022 (Syntermed, Inc., 2004) and 1 other predicate after a 58-day review. Its family tree reaches back 4 generations to 2001. 1 of the 391 devices in its family, counting itself, has a Class I recall. 380 later devices descend from it.
- Decided
- Dec 15, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010641 (2001). 10 ancestors in all, the oldest K914350 (1991). 380 later devices descend from it, 3 citing it directly. 1 of the 391 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
- 3 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
- 2 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
- 1 generation backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
- This deviceK042863 SceniumSiemens Molecular Imaging, Ltd. · 2004
- Descendant · cites it directly · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 166 of its ownK062163 MimviewerMimvista Corp. · 2006
- Descendant · 3 generations on · 120 of its ownK103785 Mobile MimMim Software, Inc. · 2011
Showing 5 of 380 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 380 · See all- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · cites it directly350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K062163MimviewerMimvista Corp. · 2006 · 2 generations on166descendants
- K103785Mobile MimMim Software, Inc. · 2011 · 3 generations on120descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010641 | GE CT-Pet System | Ge Medical Systems, Inc. | 2001 | — |
| −3 | K023988 | GE Discovery LS System | GE Medical Systems | 2003 | 1 |
| −2 | K040172 | Modification to GE Discovery LS System | GE Medical Systems | 2004 | 5 |
| −1 | K041543 | GE Discovery ST | GE Healthcare | 2004 | 1 |
| 0 (this device) | K042863 | Scenium | Siemens Molecular Imaging, Ltd. | 2004 | — |
| +1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| +3 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 14 | 0 |
| 2015 | 13 | 0 |
| 2016 | 16 | 0 |
| 2017 | 18 | 0 |
| 2018 | 26 | 0 |
| 2019 | 23 | 0 |
| 2020 | 32 | 0 |
| 2021 | 25 | 0 |
| 2022 | 32 | 0 |
| 2023 | 33 | 0 |
| 2024 | 30 | 0 |
| 2025 | 41 | 1 |
| 2026 | 37 | 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.
1 device in this family has a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K041022 | Neuroq - Pet DPSummary page 1…e Device(s): 510(lk No. Trade name Manufacturer Component Applicable to K041 022 NeuroQ TM Syntermed, Inc Displ… | 2004 |
| * | K041543 | GE Discovery STSummary page 1…____ ____ ___ __ ___ ___ ___ ___ ____ ___ ___ ___ ___ program K041543 GE Discovery ST GE Healthcare Disp… | 2004 |
What descends from it? (380)
See all 3803 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K060816 (Mimvista Corp., 2006) has gone furthest, with 350 descendants of its own.
- 6 other devices also cite its predicate K041022.
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?
Scenium display and analysis software has been developed to aid the Clinician in the
assessment and quantification of pathologies taken from PET scans.
The software is deployed via medical imaging workstations and is organised 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 studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042863: Scenium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042863
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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