# K033832: Syngo Perfusion-CT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Dec 23, 2003 after 13 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: 2 generations back to K880965 (1988). 5 ancestors in all.
194 later devices descend from it; 3 cite it directly.
1 of 200 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982536: Perfusion CT (Computed Tomography) Software Package, Siemens Corp. (1998) Summary page 2.
- K010042: CT Perfusion 2, General Electric Co. (2001) Summary page 2.

## Most influential descendants
- K050867: Syngo Body Perfusion-CT (2005), 192 descendants of its own
- 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

## Indications for use
The Siemens syngo Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves. One potential 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). Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms. A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.

Source page: https://510kreport.com/device/K033832
Methodology: https://510kreport.com/methodology