(24 days)
The Coronis Fusion 6MP DL 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.
Coronis Fusion 6MP (MDCC-6230)
The provided text is a brief FDA 510(k) clearance letter for the Barco Coronis Fusion 6MP (MDCC-6230) display system. This document grants market clearance based on substantial equivalence to a predicate device for displaying and viewing digital medical images (excluding digital mammography).
Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it is a clearance letter, not a detailed study report.
Therefore, I cannot provide the requested information from the given text.
To answer your request, a detailed performance study report or clinical validation document would be required, which is not present in the provided FDA clearance letter.
§ 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).