(35 days)
The Nio 5MP (MDNG-6121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Nio 5MP (MDNG-6121) display
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the Nio 5MP (MDNG-6121) display. This document does not contain information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, or other details typically found in a clinical study report or a more detailed technical submission.
Therefore, I cannot extract the requested information from this document. It primarily serves to state that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices for its indicated use.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).