Device Dossier

Medical image management system application software

Device Dossier for Medical image management system application software (Medical image management system application software, Class IIa, sponsor…

Intended purpose

The software is intended for use in the communication and storage of medical images. The software is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations. Due to special customer requirements based on the imaging modality and clinical focus, the software can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR). Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use. Not intended for diagnostic use on mobile devices. Rx Only

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