(75 days)
The Coronis 5MP HD (MDMG-5121) Display is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Coronis 5MP HD (MDMG-5121) display device. This document primarily focuses on the regulatory clearance process and does not contain the detailed technical specifications, acceptance criteria, or study results that would typically be found in a performance study report.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC study details from this document.
The document states the device's indications for use:
Indications For Use: The Coronis 5MP HD (MDMG-5121) Display is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
To answer your questions, I would need access to the actual technical documentation, validation reports, or performance studies submitted by Barco n.v. to the FDA, which are not part of this 510(k) 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).