# K150713: syngo.CT Myocardial Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 2, 2015 after 228 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: 8 generations back to K913770 (1991). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092013: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2009) Summary page 5.

## Most influential descendants
- K162287: Synapse 3D Perfusion Analysis (2017), 0 descendants of its own

## Indications for use
The Siemens syngo.CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium. The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media. It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

Source page: https://510kreport.com/device/K150713
Methodology: https://510kreport.com/methodology