(203 days)
The MGD 2621P Medical Grayscale Display 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.
The MGD 2621P is a diagnostic display
The provided text is a 510(k) summary for the Barco MGD 2621P Medical Grayscale Display. This document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets these criteria.
The 510(k) summary focuses on general device information, intended use, and substantial equivalence to a predicate device (Barco MGD 221 2 Megapixel Diagnostic Display - K000293). It describes the device's technical characteristics as a high-resolution monitor with electronic capabilities for evaluating high-resolution medical images.
The letter from the FDA confirms market clearance based on substantial equivalence but does not delve into specific performance studies or acceptance criteria for the display itself. It mainly cites relevant regulations and guidelines for the manufacturer.
Therefore, I cannot provide the requested table or answer questions 1-9 based on the input text. The document is essentially a regulatory clearance notice, not a detailed performance study report.
§ 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).