(96 days)
The Coronis 5MP (MDCG-5121) display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
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This document is an FDA 510(k) clearance letter for the Barco N.V. Coronis 5MP (MDCG-5121) display device. It confirms that the device is substantially equivalent to a legally marketed predicate device for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
The document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. This type of information is typically found in the 510(k) summary or the full submission, not in the clearance letter itself.
§ 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).