Intended Use

Syngo Carbon Space is indicated for display, rendering, post-processing of medical data (mostly medical images) within healthcare institutions, for example, in the field of Radiology, Nuclear Medicine, and Cardiology.

Technology

Syngo Carbon Space is a software-only, client-server medical device platform that operates on common IT hardware. It supports multi-modality imaging, DICOM/non-DICOM formats, flexible user interfaces, image processing, measurement, annotation, and seamless integration into healthcare IT networks.

Performance

Performance and verification testing was conducted via non-clinical methods, including software verification/validation and evaluation of measurement/quantification features such as lesion quantification. No new clinical studies were carried out; non-clinical performance from the predicate device is still applicable. The testing results were all found acceptable.

Predicate Devices

No predicate devices specified

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