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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.

Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.

Furthermore the syngo® InSpace 4D is embedded in the framework of a new server/client architecture also referred to as syngo® WebSpace. The server supports multiple sessions from remote "thin client" terminals at the same time. The thin client application is also a part of the syngo® WebSpace software suite, installed on a different computer, connected to the server by a network.

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.

Syngo® 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.

For a vascular evaluation the option Advanced Vessel Analysis (AVA) is designed to create an edited version of a volume to highlight and measure the vessels.

Additionally syngo® InSpace 4D is developed to facilitate fast and precise diagnosis by removing the CT table from a CT data set.

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies such as MRMC or standalone studies. The document is a 510(k) summary for a medical device, primarily focusing on its general information, intended use, device description, and substantial equivalence to a predicate device. It lacks the detailed study information you requested.

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