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Syngo MI Applications 2007A is a software product intended for use with nuclear medicine applications. It is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

It is used to detect or image the distribution of radionuclides in the body or organ(s) using the following techniques:

• planar imaging and processing .
• whole body imaging
• tomographic imaging
• . positron imaging by coincidence
• positron imaging without coincidence up to 588 keV
• display, process and fusion of nuclear medicine, SPECT, PET, CT and hybrid images.

The proposed device is a software-only update intended for use with nuclear medicine applications. The software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of:

• dedicated SPECT and PET systems, and, .
• SPECT/CT and PET/CT multi-modality systems .

The software collects clinical applications data for digital processing and viewing of images and also provides data and images for later use with third party software applications. Reviewing of images from remote locations is also possible with a limited but mobile version of this program.

The proposed device provides healthcare practitioners the ability to work with Siemens SPECT, PET, CT and other images while using standard networking and image transfer protocols such as DICOM and TCP/IP for connections to and from other devices and imaging stations. Communication capabilities consist of image review and data storage workstations through the use of the PACS protocol. Lastly, the proposed software also works with hardcopy devices, external archive devices and HIS/RIS - or Hospital Information / Radiological Information Systems.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for a software update (syngo MI Applications 2007A) for nuclear medicine applications. It describes the device, its intended use, a comparison with predicate devices, and general safety and effectiveness concerns. The core of the submission is to demonstrate substantial equivalence to previously cleared devices, not to present a de novo study with acceptance criteria and performance data.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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