# K173597: Scenium VE20 Software

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 4, 2018 after 134 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: 10 generations back to K954874 (1996). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162339: Scenium, Siemens Medical Solutions USA, Inc. (2016) Summary page 4.

## 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 databases of normal patients and normal parameters derived from these databases, derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.

Source page: https://510kreport.com/device/K173597
Methodology: https://510kreport.com/methodology