# K053024: Syngo Neuro Dsa CT

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG
- Decided: Nov 4, 2005 after 14 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: 5 generations back to K954355 (1995). 10 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043469: Syngo Inspace 4D, Siemens AG Medical Solutions (2005) Summary page 2.
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K163341: syngo.CT Extended Functionality (2017), 6 descendants of its own
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K192402: syngo.CT Extended Functionality (2019), 4 descendants of its own
- K203699: syngo. CT Extended Functionalities (2021), 3 descendants of its own
- K214019: syngo.CT Extended Functionality (2022), 1 descendant of its own

## Indications for use
syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set. Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.

Source page: https://510kreport.com/device/K053024
Methodology: https://510kreport.com/methodology