# K092013: Syngo Volume Perfusion-CT Body

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Jul 17, 2009 after 11 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: 7 generations back to K913770 (1991). 28 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073373: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2007) Summary page 2.
- K073238: Syngo Volume Perfusion-CT Neuro, Siemens AG Medical Solutions (2008) Summary page 2.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K150713: syngo.CT Myocardial Perfusion (2015), 1 descendant of its own
- K200315: Ziostation2 (2020), 0 descendants of its own
- K162287: Synapse 3D Perfusion Analysis (2017), 0 descendants of its own

## Indications for use
The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors. The software can calculate blood flow, blood volume, mean transit time 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/K092013
Methodology: https://510kreport.com/methodology