(92 days)
The Coronis 5MP (MDCG-5221) display is intended to be used in displaying digital images, for review and analysis by trained medical practitioners. It is designed for radiology and digital mammography applications.
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The provided text is a 510(k) premarket notification approval letter for the Barco Coronis 5MP (MDCG-5221) display device. This document confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory requirements.
However, this document does not contain specific information regarding:
- Acceptance criteria for device performance.
- The details of any study conducted to prove the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance (country, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for the training set was established.
The document is an administrative approval, not a technical study report. Therefore, I cannot extract the requested information from the provided text.
§ 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).