(148 days)
The Lumimed Series 5MP Digital Flat Panel Display System ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Lumimed Series 5MP Digital Flat Panel Display System™ is a flat panel hiresolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale and color image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided text is a 510(k) summary for the Lumimed Series 5MP Digital Flat Panel Display System, a medical image display system. It outlines the device's purpose, technological characteristics, and its substantial equivalence to a predicate device.
However, the document focuses on regulatory approval and does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies. The text primarily addresses the administrative and regulatory aspects of the device's clearance.
Therefore, I cannot provide the requested information from the given text. The relevant sections are entirely missing from this document.
§ 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).