# K042863: Scenium

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Molecular Imaging, Ltd.
- Decided: Dec 15, 2004 after 58 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010641 (2001). 10 ancestors in all.
380 later devices descend from it; 3 cite it directly.
1 of 391 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041022: Neuroq - Pet DP, Syntermed, Inc. (2004) Summary page 1.
- K041543: GE Discovery ST, GE Healthcare (2004) Summary page 1.

## Most influential descendants
- K060816: Mim 4.0 (Neuro (2006), 350 descendants of its own
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K062163: Mimviewer (2006), 166 descendants of its own
- K103785: Mobile Mim (2011), 120 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042863
Methodology: https://510kreport.com/methodology