# K063507: Syngo Neuro PBV CT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Nov 30, 2006 after 10 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: 6 generations back to K954355 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053024: Syngo Neuro Dsa CT, Siemens AG (2005) Summary page 2.
- K033832: Syngo Perfusion-CT, Siemens AG Medical Solutions (2003) Summary page 2.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 2.

## Indications for use
syngo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D. Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements. Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT.

Source page: https://510kreport.com/device/K063507
Methodology: https://510kreport.com/methodology