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 Feb 28, 2014 as substantially equivalent to K121074 (Siemens Medical Solutions USA, Inc., 2012) and 2 other predicates after a 93-day review. Its family tree reaches back 7 generations to 1996. 3 later devices descend from it.
- Decided
- Feb 28, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K954874 (1996). 38 ancestors in all, the oldest K885054 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 6 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 5 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 4 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 3 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 2 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 1 generation backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- This deviceK133654 SceniumSiemens Medical Solutions USA, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK150192 SceniumSiemens Medical Solutions USA, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK162339 SceniumSiemens Medical Solutions USA, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK173597 Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −6 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −5 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −4 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −3 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −2 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −1 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| 0 (this device) | K133654 | Scenium | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +1 | K150192 | Scenium | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +2 | K162339 | Scenium | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +3 | K173597 | Scenium VE20 Software | Siemens Medical Solutions USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (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 2.0 | 2012 |
| * | K071584 | Oasis Release 1.0Summary page 2…51 0(k) Number Scenium 3.0 Siemens Medical Solutions USA, Inc Ki 21074 Neurogam Oasis Segami Corporation K071 584 MIMNeuro MlMVista Corp K06081 6 Device Description: Scenium Vol10 display and analysis… | 2007 |
| * | K060816 | Mim 4.0 (NeuroSummary page 2…al Solutions USA, Inc Ki 21074 Neurogam Oasis Segami Corporation K071 584 MIMNeuro MlMVista Corp K06081 6 Device Description: Scenium Vol10 display and analysis software enables visualization and appropriate rendering of multimodalit… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150192 | Scenium | 2015 | 2 |
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 5 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K150192 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 2 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. 2014, 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…
Read the full statement (105 words)
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 FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133654: Scenium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133654
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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