# K123528: Scenium

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Dec 20, 2012 after 34 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010641 (2001). 16 ancestors in all.
79 later devices descend from it; 3 cite it directly.
0 of 96 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121074: Scenium 2.0, Siemens Medical Solutions USA, Inc. (2012) Summary page 2.
- K043441: Mirage, Release 5.5, Segami Corporation (2005) Summary page 2.
- K021656: Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4, Nuclear Diagnostics (2002) Summary page 2.

## Most influential descendants
- K130884: Xeleris 3.1 Processing and Review Workstation (2013), 77 descendants of its own
- K153355: Xeleris 4.0 Processing and Review Workstation (2016), 60 descendants of its own
- K182624: MIM - MRT Dosimetry (2018), 53 descendants of its own
- K191928: AccuContour (2020), 30 descendants of its own
- K140269: Hermes Medical Imaging Suite V5.4 (2014), 15 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K123528
Methodology: https://510kreport.com/methodology