# K073238: Syngo Volume Perfusion-CT Neuro

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Jan 3, 2008 after 48 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: 4 generations back to K880965 (1988). 8 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have 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.
- K050867: Syngo Body Perfusion-CT, Siemens AG (2005) Summary page 2.
- K052839: CT Perfusion 4, GE Healthcare (2006) Summary page 2.

## Most influential descendants
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K092013: Syngo Volume Perfusion-CT Body (2009), 6 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own
- K151988: Visible Patient Suite (2015), 4 descendants of its own
- K212896: Visible Patient Suite (2021), 3 descendants of its own

## Indications for use
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT). Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms. A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful intherapy monitoring.

Source page: https://510kreport.com/device/K073238
Methodology: https://510kreport.com/methodology