(23 days)
The Coronis 3MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Coronis 3MP (MDCG-3221)" device, which is a medical flat panel display system. This document grants market clearance based on substantial equivalence to predicate devices and does not contain the detailed study information regarding acceptance criteria and performance of the device itself.
Therefore, I cannot provide the requested information based on this document. This document primarily focuses on regulatory approval, not on the technical performance study of the device.
§ 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).