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The Sony UP-DF750 Digital Film Imager is a thermal printer intended for use in printing medical diagnostic images from mammography systems. The UP-DF750 is a multi-format imager and also is intended for printing high-resolution diagnostic images from CT, MRI, CR, DR and other compatible medical imaging systems. The Sony UP-DF750 is intended for use by medical radiologists or other appropriately trained medical personnel.

The Sony UP-DF750 Digital Film Imager is a device for digitally printing black and white still images with DICOM format. The Sony UP-DF750 Digital Film Imager is connected to a DICOM network and the image from a mammography, CT, MRI, CR, DR or other compatible medical imaging system (modality) is transmitted via the DICOM network. Whenever a DICOM file is received, the Sony UP-DF750 Digital Film Imager will understand the DICOM information and images will be formatted in the memory. Then, this information will be transferred to the Print Engine through an internal interface (VF). The data will be processed through sharpness, gamma curve and other types of compensation. The Sony UP-DF750 Digital Film Imager is intended to be used to print DICOM images obtained from a medical modality for the purpose of diagnosis.

This document is a 510(k) summary for the Sony UP-DF750 Digital Film Imager, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The purpose of a 510(k) submission is to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not to prove its performance against specific acceptance criteria through a clinical study or detailed performance evaluation.

Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with defined acceptance criteria.

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