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The In Space 3D package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

The In Space 3D package is intended for imaging both hard and soft tissues as well as other internal body structures(eg. Lesions, Stent implants) for diagnosis, surgical planning, interventional procedures and treatment follow-up.

As with the FDA cleared 3D Angio software package(K984634), this software package will also assist the physician in diagnosis and treatment of vessel malformations(i.e. Aneurysms, AVMs and Stenoses).

The In Space 3D package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

The provided text is a 510(k) summary for the Siemens In Space 3D Software Option. It describes the device, its intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill the request as the necessary information is not present in the given document. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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