# K050867: Syngo Body Perfusion-CT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Apr 14, 2005 after 8 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K880965 (1988). 6 ancestors in all.
192 later devices descend from it; 3 cite it directly.
1 of 199 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033832: Syngo Perfusion-CT, Siemens AG Medical Solutions (2003) Summary page 2.
- K010042: CT Perfusion 2, General Electric Co. (2001) Summary page 2.

## Most influential descendants
- K062351: Syngo Dual Energy (2006), 169 descendants of its own
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own

## Indications for use
The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves. A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

Source page: https://510kreport.com/device/K050867
Methodology: https://510kreport.com/methodology