# K043469: Syngo Inspace 4D

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Feb 3, 2005 after 49 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 K954355 (1995). 7 ancestors in all.
218 later devices descend from it; 5 cite it directly.
1 of 226 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011447: IN Space 3D, Siemens Medical Solutions USA, Inc. (2001) Summary page 2.

## Most influential descendants
- K071513: Inspace 4D Software Package with Extended Functionality (2007), 210 descendants of its own
- K062673: Modification to Syngo Inspace 4D (2006), 172 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

## Indications for use
syngo InSpace 4D - Software Package is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. InSpace can be used to assist the physician in the diagnosis of blood vessels on the basis of a CT Angiography dataset (CTA). For a CTA examination a contrast media (CM) is administered into the patient's blood vessels to enhance the contrast of the vessels in the CTA dataset, i.e. high values for the Hounsfield Unit (HU). The goal is to visualize the blood vessels without other interfering anatomical structures. The syngo InSpace 4D is developed to facilitate a precise diagnosis by removing bone structures from a CTA data set. It can be used in the same way for Non CTA datasets to remove bones or extract and display selected bones, e.g. for the analysis of a fracture.

Source page: https://510kreport.com/device/K043469
Methodology: https://510kreport.com/methodology