# K120331: Syngo CT Dynamic Angio

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Apr 13, 2012 after 71 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062673: Modification to Syngo Inspace 4D, Siemens AG Medical Solutions (2006) Summary page 3.
- K092013: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2009) Summary page 3.
- K073238: Syngo Volume Perfusion-CT Neuro, Siemens AG Medical Solutions (2008) Summary page 3.

## Indications for use
The syngo.CT Dynamic Angio software package has been designed to evaluate CT data which has been continuously acquired with computed tomography (CT) imaging systems. Contrast enhanced CT images are used to visualize the flow of contrast from the arteries to the veins. syngo.CT Dynamic Angio can be used to assist the physician in the diagnosis of blood vessels and it supports in the evaluation of regions of interest, the visual inspection of time attenuation curves, and the creation of specific CT volumes, for example, arterial or venous phase. It will aid in the inspection of diseases which affect the vessel system, for example, vessel stenosis, collateral or late filling of vessels, vascular malformations, control of stent graft extravasation, or in the evaluation of tumor vascularization.

Source page: https://510kreport.com/device/K120331
Methodology: https://510kreport.com/methodology